Science topic

Medical Devices - Science topic

Explore the latest questions and answers in Medical Devices, and find Medical Devices experts.
Questions related to Medical Devices
  • asked a question related to Medical Devices
Question
3 answers
In the medical device industry the application of TPS principles is primarily seen as a matter for manufacturing process and supply chain only. This is due to the regulatory environment in which they exist.
Relevant answer
Answer
I don't believe it is accurate to suggest that "TPS is based upon lean approach". Is it not more accurate to say lean is a western interpretation of Toyota methods?
  • asked a question related to Medical Devices
Question
3 answers
principles for cleaning validation for medical device and cosmetic
Relevant answer
Answer
A medical device cleaning validation requires that the device is soiled with biological material in a manner that is clinically relevant. The soil will often depend on the type of device being tested, but typically is a mixtures of proteins, hemoglobin, and carbohydrates. Artificial Test Soil (ATS) is the most commonly used soil for medical device cleaning validations. Once soiled, the medical device will be cleaned according to the manufacturer’s instructions and any remaining soil will be extracted from the device.
Manual cleaning is the most frequently requested medical device cleaning validation method, but many hospitals and clinics use automated washer disinfectors for reprocessing reusable medical devices.  Therefore, ISO standards recommend that at least one automated cleaning method be validated. An automated cleaning validation is performed the same way as a manual cleaning validation except that the actual cleaning steps are performed by an automated washer/disinfector.
Medical device disinfection validations are performed differently depending on the level of disinfection required, high level disinfection, intermediate level disinfection or low level disinfection.  The level of disinfection is determined by the Spaulding Category of the device, critical, semi-critical or non-critical.  Critical medical devices come in contact with the blood stream and sterile parts of the body.  These devices must be sterilized.  Semi-critical devices come into contact with intact mucous membrane or non-intact skin but do not normally penetrate the blood barrier or sterile area of the patient.  Semi-critical devices should be sterilized but if the device can not withstand sterilization, high level disinfection may be used. Non-critical devices only contact intact skin.  Non-critical devices can be disinfected using intermediate or low level disinfection.
All disinfection validations require that the device be inoculated with bacteria and then exposed to the disinfectant.  Any remaining bacteria is extracted from the device and grown on plates in a manner similar to a bioburden test. High level disinfection requires a six log reduction of Mycobacteria.  A three log reduction of Mycobacteria and a six log reduction of four different vegetative organisms are required for intermediate level disinfection.  Low level disinfection requires only a six log reduction of four different vegetative organism.
Sincerely ...
  • asked a question related to Medical Devices
Question
2 answers
In Europe, Medical Device Regulation (MDR) & in the USA, Food and Drug Administration (FDA) and Central Drugs Standard Control Organization (CDSCO) in India postulated stringent rules that bio-compatibility is a must for healthcare devices, especially for class-III devices.
Why bio-compatibility is necessary and what are those class-III medical devices?
Relevant answer
Answer
Hydroxyapatite is one such material.
Fluoride doped Hydroxyapatite exhibits many similarities to asbestos which is known to cause cancer in the stomach and other tissues.
Recently in Australia a famous manufacturer of infant formula was forced to withdraw product from the market due to discovery of nanocrystals of Fluoride doped Hydroxyapatite in its product.
The European Commission adopted a position on Hydroxyapatite in 2016 stating: “The available information indicates that nano-hydroxyapatite in needle-shaped form is of concern in relation to potential toxicity. Therefore, needle-shaped nano-hydroxyapatite should not be used in cosmetic products. It is of note that Material 2 of the submission also includes nanofibres of needle-like structure.”
  • asked a question related to Medical Devices
Question
2 answers
Im currently working on the thesis project on materiovigilance of ocular medical devices and despite having good theoretical knowledge, the project is not showing any progress. Is there any other approaches for the materiovigilance on ocular medical devices except observing patients for Adverse events using ocular medical devices as Interventions
Relevant answer
Answer
@neil Rothman yes i have added the ISO standards and what I'm looking for is aany good approach for the methodology for materiovigilance on ocular medical devices. The most basic one i have found is the number of events by the population. As for the FDA database, I'll use it as well. Thank you for your suggestions
  • asked a question related to Medical Devices
Question
3 answers
I am currently looking for a research in PVD coating of medical devices. I am interested on PVD coating of AlTiN for metal cause it has low reflection and is compatible for surgical instrument. I want to doping it with Ag so it has antibacterial effect. But will it make the reflection of material completely change or will it depends on Ag-doping composition?
Relevant answer
Answer
If you introduce Ag in amounts that it becomes biologically relevant, you will surely introduce major changes to the bandgap and therefore changes in the color and all optical properties would be expectable.
  • asked a question related to Medical Devices
Question
1 answer
As per title, I'm interested in knowing whether any commercially available (not research based), medical devices are manufactured (even if partly) through the polymerisation of monomers using photoinitiators such as Irgacure, Eosin-Y, riboflavin etc. Specifically, polymerisation of the material outside of the body. Equivalent to the polymerisation of a polymeric coating on a stent within a manufacturing facility.
Relevant answer
Answer
Dental prosthesis devices like dentures or aligners are made with 3D printing by DLP process.
  • asked a question related to Medical Devices
Question
6 answers
Hi,
I am planning to conduct a clinical investigation as per ISO 14155:2020 for one of our products for which the target population is neonates. Our product is already commercially available on the investigation site and it is a proven medical device, so we have confirmed for conducting an observational study.
From our understanding of ISO 14155:2020, Informed consent can be waived by the Ethical Committee, but there is also a statement that except for consent applying requirements for personal data protection. Our target population is neonates so there is no way we are going to disclose personal details.
My question is do we not need to get Informed consent from parents for this observational clinical study??
Thanks in advance!!
Relevant answer
Answer
You would first need an IRB review/approval. The IRB would determine if a written or verbal informed consent (from parents of course) is required or the informed consent could be/better be waived. In general, for a prospective, truly-observational study (intervention is entirely based on clinical practice independent of the research), a verbal consent would suffice, but it depends on extent and sensitivity of data to be collected. The ethical considerations in such studies include not only potential informational harm but also respect for autonomy.
  • asked a question related to Medical Devices
Question
4 answers
Hi Researcher,
I am trying to sterilized my medical device which is well encapsulated in PDMS. I have tried to use Autoclave sterilization at 121C for 15-20 minutes but autoclave process changes the mechanical properties of the PDMS.
Can someone guide me what type of sterilization technique will be useful here that do not impact the response and also keep the device biocompatible.
Thanks
Farooq
Relevant answer
Answer
AAMI TIR 17 Compatibility of materials subject to sterilization lists PDMS in its compatibility charts. It only lists PDMS (polydimethylsiloxane) fluid in the lubricants section. But I think that the information can probably be extracted to a solid form of PDMS. The tables list 3 possibilities for each material and whether or not the material is compatible with a specific sterilization process: NL - not likely, L - likely and U - unknown. According to the charts the following sterilization methods are NL: radiation sterilization. This method is considered poor to good but there is a tendency for problems to occur especially at higher doses or with high viscosity material. Low viscosity is more stable and lower doses may work. You might want to explore this.
Several sterilization processes are listed as unknown. These include the following: Liquid Peracetic Acid,
  • asked a question related to Medical Devices
Question
31 answers
The development of a vaccine for COVID-19 has become a battleground for many countries to prove to the world/their own peoples that their technology is superior and better than the competitors at the international stage. it is always a point of concern when science is serving the political establishment. Russia claimed that they have developed 'the first' Covid-19 vaccine. WHO is raising concern about the validity of this claim and urging Russia to provide sufficient data to back this claim.
Is it possible for the same scenario to be repeated in the US? An election is near and COVID-19 vaccine development can influence the result.
Relevant answer
Answer
Please also have a look at this useful link.
  • asked a question related to Medical Devices
Question
1 answer
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
Relevant answer
Answer
Yes, if the intended use are an implant in a human beeing it is defined as medica device in MDR and this regulation are in charge for Europeean market.
  • asked a question related to Medical Devices
Question
3 answers
Hi,
What is the best way for monitoring heart rate with medical devices for the patient suffering from severe burn? it seems to me that ECG leads cannot attach to the skin for these patients properly. Is there any kind of special contactless leads for this issue?
Relevant answer
Answer
As mentioned above, PPG is the best way. Paste PPG sensor/device on any finger, lower or upper limb. Then calibrate it , if required.
  • asked a question related to Medical Devices
Question
7 answers
EU directives on medical devices only include medical devices for human beings. Medical devices for veterinary use are not included in the legislation and therefore there is no requirement that they must be CE-marked as medical devices or meet the essential requirements for the CE marking.
In Italy there are no local regulations for the design, manufacture and marketing of medical devices for veterinary use.
What local regulations are in force in the EU and not-EU countries?
Relevant answer
Answer
Can I have the Full text article for "Note on the regulation of veterinary medical devices in the EU: A review of the current situation and its impact on animal health and safety".
Request sent to author for the access
  • asked a question related to Medical Devices
Question
3 answers
First of all, thank you for your consideration about this question.
I've been working on development of in-vitro diagnostic medical device as research engineer since 2013. Especially, my major is to develop kit using colorimetric method, immunoassay and electrochemistry method.
Btw, I am wondering how could I remove the positive signal at the zero concentration when using colorimetric method. In other words, sometimes I face difficulties because color reaction occurs at zero concentration (There is no substrate I want to analyse).
Please kindly share your advice.
Relevant answer
Answer
Hi...you can be by adding the inhibiting agent with the reaction mixture ... or we can use the blank solution
  • asked a question related to Medical Devices
Question
9 answers
Hi, I did a literature review on innovation diffusion theories (Rogers), and I attempted to test the practicality of these theories when introducing novel medical devices. I did semi-structured interviews with clinicians. So is it correct that I am using a deductive method since I am looking for existing concepts in my data? What method should I use to analyse the interviews? Thematic? Content? Thank you!
Relevant answer
Answer
Hopefully the following publications could help:
  • Attride-stirling, J. (2001) Thematic networks: an analytic tool for qualitative research, Qualitative Research, 1, 3, pp. 385-405.
  • Braun, V. and Clarke, V. (2006) Using thematic analysis in psychology, Qualitative Research in Psychology, 3, 2, pp. 77-101.
  • Braun, V. and Clarke, V. (2014) Editorial : What can ‘‘thematic analysis’’ offer health and wellbeing researchers?, International Journal of Qualitative Studies on Health and Well-being, 9, 1, pp. 1-2.
  • Joffe, H. (2012) Thematic Analysis, in Harper, D. and Thompson, A.R. (eds.) Qualitative methods in mental health and psychotherapy: A guide for students and practitioners. West Sussex, UK: John Wiley & Sons, Ltd, pp. 209-223.
  • asked a question related to Medical Devices
Question
8 answers
What are different coil shapes used in Transcranial Magnetic Stimulation? What are their differences (in induced current)? Do they have different applications?
Relevant answer
Answer
Hi,
Actually, the influence of inductance value in a coil on TMS is eddy current strength. In addition, the coil design in physical configuration can affect the TMS distribution or depth. The TMS coil with eight shapes is commonly used in clinical application due to better high resolution than the round coil.
You can refer to the article below. Good luck!
  • asked a question related to Medical Devices
Question
2 answers
Hello,
we are conducting cytotoxicity tests since over an year and aren't able to get a stable test. We are no in the validation phase but there are some effects we can't explain. Here is an overview how we conduct the test in compliance with DIN EN ISO 10993-5:
- Seeding 1 x 10^4 cells in a 96-well plate (except the outer wells) --> incubate for 24 h
- Adding medical device extracts (100%, 50%, 10%, 1%) and controls:
- positive control: 1% Triton X (P)
- negative control: cell media (N)
- blank (B): media that was shaken with cell culture media for 24 h at 37 °C in the same kind of container like the medical device was shaken (in compliance with DIN EN ISO 10993-12)
- Incubation for 24 h
- Discard the media and add 50 µl MTT solution (10 mg/ml) --> incubate for 2 h
- Discard and add 100 µl Isopropanol --> incubate for 30 min
- Read out with microplate reader
See the pictures below...the cells are all the time okay until extracts and controlls are added...So something must happen at this point. Sometimes the negative control dies randomly. Sometimes the blank dies. Sometimes only one extract dilution which makes no sense. Does anyone have an idea?
Many thanks!
Relevant answer
Answer
I have had enough failures in doing cytotoxicity and viability assays to be able to share some insights.
1. I don't know your cell line but if the cells are average sized and multiply properly, I would start by seeding a lower cell density around 1-2k cells per well. Lower cells density allows us to see a better resolution of effect by the agent/ controls on cell survival/viability/proliferation.
2. The most common but less discussed issue is changing media. Everyone you change media due to pipetting a large chunk of cells may be pipetted out. Resulting in negative results in one of the agents or positive controls. Many a times when cell density is very high a large chunk of cells gets uprooted out easily. So without touching the bottom the pipette needs to be touching the edge to gently remove media. This should be practiced throughout all media changes.
3. Another alternative is to avoid change of media as much as possible. One way is to directly put the MTT in the media. Although media has a colour due to phenol red it may affect reading but the media is present in all wells so it should not be an issue. Although some people use a media without phenol red to avoid this issue.
Hope this helps.
  • asked a question related to Medical Devices
Question
1 answer
for use of medical device HASS test in the body fluid.
Relevant answer
Answer
This links have good information
  • asked a question related to Medical Devices
Question
7 answers
I am going to combine the antibiotic for coating on medical devices.
Relevant answer
Answer
As Escherichia coli is being rifampicin-resistance, this antibiotic must be stopped and replaced with ciprofloxacin.
  • asked a question related to Medical Devices
Question
9 answers
Hello,
Supported by medical teams in France, we were asking to investigate on medical filter alternatives in case of emergency measures. For sure it won't replace normed medical device, but it could be better that tissue/clothe around mouth and nose.
We are currently 3d-printing facial mask (based on tpu shore 95) as alternative to the lack of standard medical filtration masks (out of stock). We are materials physico-chemist and manage the 3d printing of the mask solid support, but not specialists in membrane filtration or medical device. We understood that it required filtration for droplets bigger than 5 microns, but maybe also aerosols droplets (<5microns) in ideal case.
WE NEED YOUR HELP to know which material could be used as filter integrated the whole device (see picture of the 3d printed masks). The filter can be changed easily and the mask support cleaned (detergent, alcohol and temperature).
Candidate materials FOR FILTERS :
It could be already manufactured existing products (cotton wheel for make up, tissue, sponge, vaccum cleaner...) or any product that could be easily manufactured in large volume?
If you have any advice or recommendations, please help us. We need interdisciplinary collaboration.
Here can be download the open sources STL to 3d-printed the mask (NanoHack STL digital Files) here:
I kindly thank you for your help,
Support to all.
Dr Sophie Groult
Relevant answer
Answer
The filtering material of your medical device should comply with the requirements of the standard EN 14683:2019 Medical face masks - Requirements and test methods.
The standard lists the methods for mechanical and microbiological tests of the mask and the criteria for the acceptability of the filter material.
The good news is that this standard and other useful documents for the design and testing of face masks are available for free on the CEN website at:
Hoping to have helped you a bit.
  • asked a question related to Medical Devices
Question
3 answers
Dear Colleague,
due to the COVID-19, IEEE ICTS4eHealth 2020 will be held virtually.
Authors of the accepted papers will be invited to upload a 15 minutes presentation of their work, and their video will be available through this website to all interested readers.
Accepted papers will be anyway included in the ISCC 2020 Proceedings, and will be submitted for inclusion to IEEE Xplore. The ISCC Proceedings have been indexed in the past by ISI, dblp, and Scopus.
For each paper accepted at ICTS4eHealth workshop, one of the authors will have to pay a reduced fee just to cover the IEEExplore costs:
• IEEE Author Member Fee: 100 Euros
• IEEE Authors Non-Member Fee: 125 Euros
Authors of selected papers will be invited to submit an extended version in the IEEE Journal of Biomedical and Health Informatics (WoS Impact Factor 4.217, Scopus SJR 1.122) - Special Issue on "Enabling Technologies for Next Generation Telehealthcare".
=======================================================
ICTS4eHealth 2020
5th edition of the IEEE International Workshop on ICT Solutions for
e-Health
in conjunction with the Twenty-Five IEEE Symposium on Computers and Communications
=======================================================
MISSION:
-----------------------------------------------------------------------------------------------
e-Health is one of the major research topics that have been attracting cross-disciplinary research groups. The deployment of new emerging ICT technologies for Health, especially based on Cloud computing, the Internet of Things (IoT), and Computational Intelligence, is attracting the interest of many researchers. The use of Cloud computing, IoT technologies, and methods typical of Soft Computing and Computational Intelligence have been very prominent recently and can be of great help in finding good solutions to many practical healthcare applications.
TOPICS:
-----------------------------------------------------------------------------------------------
- Cloud computing applications for eHealth
- Internet of Things (IoT) applications for eHealth
- Assistive Technology (AT).
- Informatization, Management and Organization of BME Environments
- Bioinformatics and Computational Biology and Medicine
- Communication, Networking and Monitoring in Bio-systems
- Monitoring of Vital Functions with Sensor and ICT Systems
- Biosensors and Sensor Networks
- Advanced Bio-signal Processing
- Distributed BME Applications
- Telehealth, Telecare, Telemonitoring, Telediagnostics
- e-Healthcare, m-Healthcare, x-Health
- Assisted Living
- Smartphones in BME Applications
- Social Networking, Computing and Education for Health
- Computer Aided Diagnostics
- Improved Therapeutic and Rehabilitation Methods
- Intelligent Bio-signal Interpretation
- Data and Visual Mining for Diagnostics
- Advanced Medical Visualization Techniques
- Personalized Medical Devices and Approaches
- Modelling and Computer Simulations in BME
- Human Responses in Extreme Environments
- Other Emerging Topics in BME
- E-Accessibility
- Web accessibility
- Hardware & Software personalized assistive technologies
- Assistive systems for users who are blind or visually impaired
- Cloud computing and AT
- Integration between home-based assistive technologies and patient health data
- User-centered design of electronic assistive technologies
- Usability of assistive technologies
- Computer vision in AT
- User interfaces for home-based assistive technologies
- Use of prescription systems and assistive technologies
- Experience from real world assistive environment deployment
- Assistive Technologies for Urban Environments
- Healthcare modeling and simulation
- Knowledge discovery and decision support
- Biomedical data processing
- Wearable devices
- Sensor-based mHealth applications
IMPORTANT DATES:
-----------------------------------------------------------------------------------------------
• Submission deadline: May 09, 2020 (extended - firm deadline!)
• Notification of paper acceptance: May 29, 2020
• Submission of camera-ready papers: June 08, 2020
• Registration: June 08, 2020
PAPER SUBMISSION:
-----------------------------------------------------------------------------------------------
Manuscripts should describe original work and should be no more than 7 pages for full papers and 4 pages for short papers in the IEEE double column proceedings format including tables, figures and references. Download manuscript templates for IEEE conference proceedings here.
All papers should be submitted via EasyChair using the following link https://easychair.org/conferences/?conf=ieeeiscc2020 and selecting "ICTS4eHealth Workshop" track.
Authors must use the IEEE conference proceedings format obtainable at: https://www.ieee.org/conferences_events/conferences/publishing/templates.html
SPECIAL ISSUE:
-----------------------------------------------------------------------------------------------
IEEE Journal of Biomedical and Health Informatics:
J.BHI Special Issue on “Enabling Technologies for Next Generation Telehealthcare”
BEST PAPER AWARD:
-----------------------------------------------------------------------------------------------
A "Best Paper Award" Certificate will be conferred on the author(s) of a paper presented at the workshop, selected by the Chairs based on scientific significance, originality and outstanding technical quality of the paper, as assessed also by the evaluations of the members of the Program Committee.
Please visit http://icts4ehealth.icar.cnr.it for more information and if you have any questions kindly get back to us by sending an email at icts4ehealth@googlegroups.com.
Kind regards,
icts4ehealth Organization
Relevant answer
Answer
Do they still accepting papers?
  • asked a question related to Medical Devices
Question
2 answers
The diversity of medical devices, their increasing complexity, as well as the development of devices for personal use have increased the risk associated with misuse. The use made by "operators", by health professionals as well as patient himself must also be carefully evaluated to reduce the risk of incidents. Finally, the global environment (care structure, nursing home, home etc.) must also be taken into account. The concept of user experience indeed takes on its full meaning by aggregating the factors linked to the end-user, the device and their environment.
The design of clinical studies on the drug focuses on the pharmacological action of the product, trying to eliminate all biases related to the user, the context and the patient through randomization. But is this what should be done for the clinical evaluation of a new medical device, or should we imagine methodologies that, unlike drugs, would take into account users and their environment?
Relevant answer
Answer
The clinical evaluation should not simply "rely, in principle, on clinical data" but "on clinical data that provide clinical evidence enough", the level of which must be "motivated" by the manufacturer and "appropriate" in consideration of the characteristics of the device and its intended use.
Demonstration of conformity with the general safety and performance requirements not based on clinical data must have appropriate justification, based on the results of risk management performed by the manufacturer, as well as on the results of non-clinical testing methods, including performance evaluation , bench tests and pre-clinical evaluation.
  • asked a question related to Medical Devices
Question
1 answer
We have a machine which has a chamber that is used to dry small medical samples. The machine, generally speaking, applies multiple cycles of vacuum and dry nitrogen washings in order to get the relative humidity as low as possible. However, the machine recently seems to have inefficiency problems making it unable to lower the relative humidity to less than 10-15%. Currently, we do not have the means to change, fix, or diagnose the machine, so I have to find a solution for this issue by adding some sort of desiccants in order to lower the relative humidity even more. We have some silica gel that we are experimenting with, but the results do not seem so promising. Silica gel, as far as I could understand, does not desiccate efficiently with its full capacity in such conditions where temperature is relatively high (40-60°C) and relative humidity levels are below 50%. According to my research in the scientific literature, molecular sieve or desiccant clays (like Desi Pak® Bentonite Clay) might be a better solution for me, but I not sure and I am not able find something definitive and direct regarding this issue without diving deep in this topic which I do not know very well.
So, can someone please direct me to right choice, or at least help me to get to choose the best solution for my purposes. The conditions are:
  • Temperature is between 40 and 60°C
  • Relative humidity is generally less than 50%
  • Air pressure inside can get as low as 50 mBar.
  • No active air circulation inside the chamber.
  • Samples are place for about 3-8 hours.
  • The volume of the chamber is less than 500 liters.
Thanks in advance.
Relevant answer
Answer
find the following article, I hope it will be helpful to you
  • asked a question related to Medical Devices
Question
4 answers
The failure of physicians who write papers on medical devices to actually mention the NAME of the medical device they used in the research is going to kill a lot of people when those medical devices fall off the market for lack of clinical data.
Relevant answer
Answer
Agreed on all points.
  • asked a question related to Medical Devices
Question
3 answers
Hello everyone,
if a medical device that is already approved in the US should be modified with a drug component, what would be the difference in the FDA approval process, between an approved and an unapproved drug?
If the drug is unapproved, does that mean that approval of the MD is not possible?
Relevant answer
Answer
FDA Quality Systems Requirements for Pre-Filled Injection Devices
The FDA has put out the “Current Good Manufacturing Practice Requirements for Combination Products” which is 21 CFR Part 4 and is a final rule effective as of July 22, 2013. The rule requires combination product manufacturers to comply with both Current Good Manufacturing Practice regulations for drugs and biologics (21 CFR 210, 211 (CGMP)) and the Quality System Regulation for medical devices (21 CFR 820 (QSR)), during and after formation of a combination product. This has significant implications for pharmaceutical and medical device manufacturers that produce medicated devices, prefilled drug delivery devices and their components. This means that pharmaceutical and medical device manufacturers producing medicated devices, prefilled injection devices and/or their components, or filling prefilled syringes or assembling drug delivery devices should be in compliance with the regulation. Failure to comply will be a violation of the Federal Food, Drug, and Cosmetic Act. According to FDA’s combination product definitions in the Product Jurisdiction Regulation, prefilled drug delivery devices such as prefilled syringes, auto-injectors and pens containing drugs or biologics are combination products. Some manufacturers prefer to consider syringe components as components of a pharmaceutical container closure or primary parenteral packaging system.
While the syringe constituent part of a prefilled syringe is a container closure system, syringe components, once assembled, form a syringe, which is a medical device. Filling a medical device with a drug formulation creates a combination product. FDA has the authority to apply drug, biologic and medical device regulations to any product composed of a drug or biologic and medical device constituent parts.
Thus, FDA can require medical device, drug or biologic manufacturers of combination products and/or their constituent parts to comply with applicable requirements of the both QSR and the CGMP regulations.
According to the quality system rule for combination products, when the constituent parts of a combination product are manufactured separately and remain separate, each is subject only to the regulation that pertains to that type of constituent part. When the constituent parts of a combination product are combined to form a single-entity combination product, or are co-packaged to form a kit combination product, the constituent parts retain their regulatory status both before and after they are combined. When the constituent parts are combined or co-packaged, quality system requirements that apply separately to each constituent part also apply to the entire combination product.
FDA considers the QSR and CGMP regulations to be similar and overlapping. Each regulation is designed to fit the characteristics of the products it regulates. The effective quality system rule for combination products suggests specific requirements of one regulation can be satisfied, perhaps with some fine tuning,
by complying with a general requirement of the counterpart regulation. For manufacturers of single-entity and kit combination products containing drug (or biologic) and device constituent parts, rather than implementing multiple and potentially redundant quality systems, the effective rule allows compliance with either the cGMP or the QSR to satisfy most requirements.
Development Partner, Vendor and Contractor Compliance
The manufacturer of a combination product has the overarching responsibility for assuring compliance with relevant quality system regulations. Any development partner, vendor or contract manufacturer that joins the drug and device constituent parts of a combination product will need to be in compliance with more than one quality regulation. If a combination product manufacturer is not involved in establishing or changing an existing design specification for a drug delivery device or does not change the intended use of an existing medical
device constituent part of a combination product, it must assure that its co-development partner, vendor and/or contractor, at minimum, is compliant with applicable elements of the QSR.
If a pharmaceutical company chooses to either outsource device development or allow a development partner, vendor or contractor to modify an existing device to meet specified requirements, or if the pharmaceutical manufacturer is involved in establishing device design requirements, it will need to be effectively involved in the device design control process and its quality system procedures should reflect this.
Combination products are defined in 21 CFR 3.2(e). The term combination product includes
 A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single
entity;
 Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
 A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where
both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use,
dosage form, strength, route of administration, or significant change in dose
 Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where
both are required to achieve the intended use, indication, or effect.
So by definition, a drug–drug, biologic–biologic, or device–device does not constitute a combination product.
Primary Mode of Action in the US
Formal Agency determination via the Office of Combination Products (OCP)
60-day process: Request for Designation (RFD) Process [21CFR3.7] based on
 Product consistency with similar Combination Products
 Expertise/experience of Centers in evaluating Combination Products.
 Scientific evaluation, if enough information is available FDA Center leading the review of a Combination Product assigned depending on PMOA= “the single mode of action of a Combination product that provides the
most important therapeutic action”
 Biologic part - CBER, Center for Biologics Evaluation and Research
 Drug part CDER, Center for Drug Evaluation and Research
 Device part - CDRH, Center for Devices and Radiological Health
Manufacturers of prefilled drug delivery devices and their components need to be prepared for compliance with the 21 CFR Part 4 quality system regulation for combination products. Combination product and constituent part developers, manufacturers and their development partners, vendors and/or contractors should assess, and where necessary enhance, their quality systems and those of their development partners, vendors and contractors to assure they will be in full compliance with the 21 CFR Part 4 requirements.
Implementing changes to an existing quality system requires planning, time and expertise. Quality system gap assessments should evaluate existing quality systems in the context of the combination products and/or constituent
parts being developed and manufactured. These assessments should include a review of purchasing agreements, quality policy and procedures.
To fill the gaps, supplemental standard operating procedures (SOPs) and quality policy elements will need to be established. Which gaps need to be filled will depend on the development and manufacturing activities performed
and the nature of the combination product. Manufacturers of prefilled drug delivery systems that engage in even the best CGMP industry practice still will need to incorporate additional elements of the QSR that are unique to medical
device quality system practice into existing quality policies and SOPs.
Development partners, manufacturers and/or vendors of device constituent parts whose quality systems conform to only the ISO 13485 or ISO 15378 standards may need to enhance their quality systems by adding, as appropriate,
additional QSR elements.
  • asked a question related to Medical Devices
Question
9 answers
Medical devices cover a wide range of products ranging from eyeglasses to active coronary stent, via wheelchairs. Medical devices are also characterized by a short life in the market, small patient populations and a high potential for innovation. Do you think it is necessary to distinguish different clinical study methods for the authorization of new medical devices to be marketed according to their level of risk?
Relevant answer
Answer
Risk management should take into account all sources of potential hazard to the health and safety of a patient, including user expertise (eg, education), training (eg, company device training) and environment (eg, is the clinical lab adequately equipped?). Normally this is required to qualify a user prior to participating in a clinical study, or as a condition for device purchase after market approval. Of course this hasn't been ideal as many adverse events occur due to user error. It should be noted here that another obvious source of risk is the state of disease itself. Devices and training might be optimal, yet the patient's anatomy and disease can present treatment challenges.
  • asked a question related to Medical Devices
Question
5 answers
Medical devices cover a wide range of products ranging from crutch to active pace-maker, via hip prothesis. Classification according to risk in Europe (class I, IIa, IIb or III) or in US allows to get as close as possible to the concept of high risk. But the high risk and these classes do not necessarily overlap completely, and some divergences appear on both sides of the Atlantic Ocean. Do you have any useful elements of high risk definition to facilitate the classification of new medical devices entering the market, all of which, in principle, require clinical investigation?
Relevant answer
Answer
The difficulty lies in the initial classification of a new device, and the initial assessment of its level of risk. I took the example of the hip prosthesis, because it is classified in Europe in class III (the highest risk) while it is considered in the US in class II American (see : https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=LPH ). In this specific case, the regulatory demands are indeed different.
As you point out, few clinical studies are carried out for medical devices, especially when they follow a 510k process instead of a Premarket approval (PMA). Do you think that a high-risk classification should systematically lead to the performance of a demonstrative clinical study before obtaining marketing authorization, and if so, what would be your arguments for asking for it?
  • asked a question related to Medical Devices
Question
1 answer
I am aware of a FDA guidance for inter species drug dosage relation. If the dosage is plated on a medical device and is slowly released- Efficacy extrapolation for an antimicrobial medical implant surface against bacteria for instance, how do we approach that scenario?
Relevant answer
J Tissue Eng. 2018 Jan-Dec; 9: 2041731418789838.
Antibacterial surface modification of titanium implants in orthopaedics
Wich Orapiriyakul, Peter S Young, Laila Damiati, and Penelope M Tsimbouri
This paper can be helpful and the researchers could be on RG and may discuss the issue with you.
  • asked a question related to Medical Devices
Question
4 answers
Whilst we are awaiting evidence of all types, what is the best current evidence for orthopaedic robots?
In the future, there are many possible study designs and outcome measures. Medical device research is confounded by the inability to blind the surgeon and the varied surgical technique. Registry data may give the answer in the long term but is likely to be confounded by experienced surgeons using the robot and fit patients selecting the robot.
Is the best outcome measure 3D CT measured implant position of robotic vs human ?
Relevant answer
Answer
I attended a demonstration of Stryker's arthroplasty robot (Mako), which is currently being introduced in the UK via private healthcare companies (BMI). I discussed theatre aspects of this approach and whilst the surgery duration has not changed between standard or robotic approach, the incisions are small and patients that were available to talk to on the day had reported a shorter length of stay and improved outcomes. The use of CT imaging as a guide during surgery I found particularly interesting as Surgeons are able to take templating one step further and account for all types of structural differences and by using the robot this can be precision cutting. Kayani (2018 - Bone & J Journal) has produced some research on knee arthroplasty and there is a systematic review by Chen (2018) that might be of use?
  • asked a question related to Medical Devices
Question
88 answers
I have been trying to data and wave capture from Philips IntelliVue Monitor using Matlab for our research studies in real time. Does anyone have some code they are willing to share? The community's help in this important matter?
Relevant answer
Answer
There are two types of connectors on Intellivue platform, the MIB (ISO/IEEE framing) which is similar to RS232 but has a RJ45 type connector with specific wiring. The other type is regular LAN port which can be connected to a PC via a crossover LAN cable or even a regular crossover cable with Internet sharing or router configuration. See some details here: https://sourceforge.net/p/vscapture/discussion/general/thread/d87f964f/#32be and here https://sourceforge.net/p/vscapture/discussion/general/thread/cb369fa9/
  • asked a question related to Medical Devices
Question
5 answers
Greetings colleagues!
I really hope you could devote some of your time to the following: 
We are now designing a new dental implant (Class III).
During preclinical stage in vitro and in vivo studies were done. We want to verify the implant by designing a clinical trial, but before that all preclinical studies must be done.
What studies must be included in preclinics to measure safety (technical, biocompatibility etc) by ISO standards? As we know ISO-10993(bio) and ISO-14801(tech) are widely used for dental implants.
May be you can suggest a better tactics to check safety of the medical device?
Relevant answer
Answer
All FDA does is to allow marketing of food, drugs, devices based upon safety and efficacy. If a device is to be sold in the United States then it must have FDA clearance to do so. FDA does not test, It does not approve, it evaluates data, I guess that's easiest way to say it. So asking what must be done to allow a medical device to be "approved" does not demonstrate a clear understanding of what the FDA does and does not do.
A person who has "invented" a specific device can start using it in the treatment of their patients whenever they want to as long as they are willing to accept the medical legal risk. They can give it to their friends and their friends can use it to treat patients, pay they could give it to their enemies and their enemies could use it to treat patients too but that's old different story. The problem comes when there is a commercial use of a device. For all intents and purposes it has to be across state lines because it fits within this particular state it still comes down to individual states rights and the individual states can make decisions regarding the use or nonuse of a device within their own state.
  • asked a question related to Medical Devices
Question
1 answer
Hi,
We use natural rubber to show cytotoxic response to our HFC for MEM elution method. However, sometime the natural rubber does not show a positive response and the whole assay is invalidated. I am wandering if there are other options to be used as cytotoxic positive controls. Thanks for help and a reference to literature or ISO guidelines will be helpful.
Relevant answer
Answer
Hello Swati,
It is some years since I was doing these studies but I remember that we had good success using elastic rubber bands. However, if you prefer to be more precise then you can use standard materials such as polyurethane films containing various amounts of cytotoxic compounds such as zinc diethyldithiocarbamate (ZDEC) and zinc dibutyldithiocarbamate (ZDBC). The ZDEC and ZDBC polyurethanes are available from the Food and Drug Safety Center, Hatano Research Institute, Ochiai 729-5, Hadanoshi, Kanagawa 257, Japan. I also remember a US supplier of positive control discs, although I cannot find the details. As a last suggestion then you can prepare your own paper filter discs with a known amount of a toxic zinc salt solution that can be used after drying.
Regards,
Peter
  • asked a question related to Medical Devices
Question
4 answers
I am reading studies evaluating the effectiveness of a medical device for improving scars. The studies I have found so far seem to have small sample sizes, ranging from 10 to 25, except one which included 47 patients. None of investigators performed calculations to determine if the studies were adequately powered. However, they reported statistical significance based on p-value of 0.05 or less, but without any indication of variability such as confidence intervals. I am unsure if these studies were sufficiently powered. And, I am wondering how accurate it will be for one to conclude that the studies were adequately powered based on the p-values. I will greatly appreciate any references to peer-reviewed literature on this issue. Thank you.
Relevant answer
Answer
Much thanks David
  • asked a question related to Medical Devices
Question
3 answers
In medical device development definition phase, as new system features are introduced, are there any general categories which should form the basis for defining requirements for this new feature(s)?
Relevant answer
Answer
Hello Rahul,
As outlined by Ani, you do not have much meat to chew on for information. Nonetheless, notwithstanding, from your information it seems that there is two (2) systems to be taken care of.
1) Your elector-mechanical system.
2) The software.
As per ISO13485 and FDA 21 CFR 820 the following requires to be done prior to putting a system on line.
1) URS (User Requirement Specification).
2) FRS (Functional Requirement Specification).
3) Purpose: To ensure that the Design Control elements of whatever you are trying to implement will consistently support the objective of meeting or exceeding the customer expectation for product safety and performance while meeting the domestic and international regulatory compliance requirements for design control.
4) You require to develop the following:
· Design and Development Plan
· Scaling Plan
· Project Contract
· Design Inputs
· Design Outputs
· Design Reviews
· Design Verification
· Design Validation
· Design Transfer
· Design Changes
· Design History File
5) The Design Control elements should be integrated into your Product Development Process (PDP), which is comprised of five phases:
• Proposal
• Definition
• Development
• Validation and Scale-up
• Commercialization
Design Controls are initiated with the approval and control of the Market Specification at the end of the Proposal Phase.
Design and Development Planning shall be completed through the Scaling Plan, Project Contract and Design Control elements planning documents such as Design Verification Master Plan, the Master Validation Plan, Design Validation Plan and the Quality Plan
• Each phase, after Proposal Phase, shall begin with the review and approval, if revised, of a business plan and associated Scaling Plan in accordance with the PDP.
• Each phase has a set of Design Control deliverables as described in the Scaling Plan that must be addressed before the phase is considered to be complete.
Design Inputs shall be identified and documented in the Market Specification per Product Specifications, and are those requirements essential for product design and development to meet intended use and product requirements.
Design Outputs are the established deliverables demonstrating that the product design satisfies the Design Inputs, and this is the basis for the Device Master Record (DMR). The design outputs shall be defined and documented in engineering documentation (e.g., drawings), manufacturing procedures, and the records established in the Design History File (DHF).
Design Reviews are formal reviews held at planned stages in the Product Development Process (PDP) and assess the progress and performance of the product design and development per requirements and specifications.
Design Verification shall demonstrate that design outputs meet design inputs.
Design Validation shall demonstrate that the device specifications conform with user needs and intended use(s).
A Design History File shall be established and maintained for all approved projects.
Design Transfer confirms the review and approval of design and development activities in order to transfer the design to manufacturing. Design Transfer planning is documented through the Master Validation Plan and Quality Plan and outputs reviewed through the Design Transfer Design Review process.
Product Release confirms the review and approval of design and development activities in order to release the product. This shall be documented through the Design Review process and the Product Release process.
Design Changes shall be assessed and verified and/or validated based on the extent of the change in accordance with established design control policies and procedures.
Device Master Record (DMR) shall be established for each device. The DMR shall include, or refer to the location of, the following information:
Device Specification (including material specifications, software specifications, packaging specification, labeling specifications (including shelf life), etc.)
Product Drawings (including components, sub-assemblies, in-process drawings etc.)
Production Procedures (including manufacturing, inspection, associated facility procedures, equipment specifications and procedures including calibration and maintenance)
QA Procedures (including test procedures, acceptance criteria etc.)
Packaging and Labeling Specifications (including label artwork, DFU, packaging equipment and specifications etc.)
• Installation, maintenance, and servicing procedures and methods for capital equipment.
Process Scaling and Design Control
The PDP describes the steps, tasks and deliverables to complete a product development project. Not every element of the PDP may be required, based on the size, scope and complexity of the project.
The PDP provides guidance for Core Teams to scale the requirements to the size, scope and complexity of the project. The Core Team is responsible for recommending the appropriate level of scaling for their project.
The plan for scaling any elements for Design Control shall be formally approved by the end of Definition Phase by the appropriate Project Investment Board Chair on behalf of the Project Investment Board (PIB).
Responsibility and Resources
· Projects are initiated upon management approval of a Project Proposal.
· Staffing requirements to achieve the design control elements for a given project shall be identified, reviewed and approved by the appropriate PIB and functional management.
· Coordination of project activities is assigned to a Core Team Leader, designated by the PIB chair.
· Functional Management is responsible for designating Core Team and Extended team members and for reviewing team activities and outcomes as described in the PDP and in the Design Review SOP.
· The Core Team, led by a Core Team Leader and typically consisting of members from R & D, Marketing, Operations, Process Engineering, Quality, and Regulatory Affairs, shares responsibility for assuring that Design Control requirements are met.
· The Design Control system is audited annually by Corporate Compliance and is monitored by R&D and Quality management during project related functional management activities (e.g. review of plans; Design Review etc.) Responsibility for design control deliverables is defined within the PDP and the corporate-level design control documents.
Design and Development Planning
Design and Development Planning is completed through the use of the Scaling Plan and the Project Contract.
Scaling Plan:
The completed Scaling Plan provides:
· Identification of Design Control deliverables
· Determination of which deliverables are appropriate for the project
· Rationale for deliverables which are “scaled out” (i.e. deemed not appropriate for the project)
· Assignment of the function and/or person responsible for each deliverable.
Project Contract:
The project contract is an agreement between the project team and the Project Investment Board (PIB) on the timing of completion of key project deliverables and phase transitions.
Additional Design and Development Planning:
These planning elements include:
· Plans completed for specific design control elements, such as Design Verification and Design Validation.
· Master Validation Plan for the associated process validations.
· Quality Planning.
Design Inputs
Design Inputs are initiated with a Market Specification and are translated into engineering requirements through the Product Specification. Customer requirements are documented in the Market Specification.
Design Outputs
Outputs are established in the following documents:
· Device Master Record (DMR), which lists applicable controlled documents such as drawings, manufacturing procedures, inspection procedures
· Testing protocols and acceptance criteria and testing reports (may include Verification and Validation reports).
· Domestic and International Regulatory Submissions (including FDA Submission and EC Design Dossier or Technical File, as appropriate).
· Manufacturing Procedures, Prints and Inspection Procedures.
· Design History File (DHF).
Design Reviews
Design reviews are documented, comprehensive, and systematic examinations of development results that evaluate the adequacy of the design requirements and the capability of the design to meet the requirements.
Design reviews shall be conducted and which includes representation from appropriate functions.
At a minimum, design reviews are conducted at the following planned milestones in the Product Development Process.
Review Objectives
Product Specification
To ensure that the Market Specification and Product Specification are aligned and compatible.
Initial review of the translation of customer requirements (documented in the Market Specification) into engineering requirements documented in a Product Specification to ensure they are aligned and compatible
Design Freeze
To lock design specifications as described in the Product Specification and review the associated Engineering documentation such as drawings, and component specifications that reflect these requirements.
Design Verification
Ensure that the design outputs meet the design input requirements as defined in the Product Specification.
Review Objectives
First Human Use
Demonstrate that product is safe for human use.
This review shall be conducted if product is to be approved for human use prior to completion of the Design Transfer Review.
Design Transfer
Verify the necessary activities to ensure effective and repeatable manufacturing of the documented design have been successfully completed.
Design Verification and Validation
Designs are verified and validated through testing, inspection and/or evaluation and assessment activities.
Item Description
Design Verification
Design Verification occurs primarily in the Development Phase of the Product Development Process
Design Verification is documented evidence, including product test, inspection and analytical protocols, procedures, and reports, which demonstrate that the design output meets the associated design inputs defined in the Product Specification.
Design Validation
Design Validation occurs primarily in the Development or Validation & Scale-up Phases and is conducted to demonstrate that the product conforms to the user needs and intended uses as defined in the Market Specification.
Design Transfer
Design Transfer occurs prior to commercialization of the product and demonstrates successful transfer of design requirements to production and includes completion of elements such as training, process verification and validation, design validation, implementation of process specifications and process controls/monitoring, and closure of design review action items.
Design Transfer is reviewed as part of the Design Review process.
Product Release Requirements
No "human use" of any devices built within the Design Control process shall occur without a formal review to assure clinical risk/benefit analysis of the device is acceptable and that all quality assurances have been reviewed, discussed and approved. These assurances include:
· Applicable Regulatory Requirements
· Design Verification and simulated use Design Validation
· Traceability Requirements
· Risk Management
· Appropriate Visual, Dimensional and Functional Inspections
· Appropriate Product/Process/Machine/Software Validations and Qualifications
· Microbiological and Sterility Tests
· Requirements for Packaging, Labeling (including Directions For Use)
Product distribution requirements following completion of the Design Control elements shall be identified and approved as part of the Product Release Requirements. This section is applicable for First Human Use as well as projects released through Design Transfer.
Design Changes
The development, review, and approval of documents relating to product design are controlled per requirements of the Document Control and Corporate Design Control systems.
The guiding principal of this policy is that the level of documentation and evaluation should be in direct proportion to the significance of the design change.
Design Change during PDP:
When design changes are made during the PDP, all controlled documentation such as the Marketing Specification; Product Specification, etc. shall be reviewed to assess the impact of the design change.
The verification and/or validation tests that were developed for initial release must be performed unless a rationale can be documented in the Design and Development Plan documents to support execution of only a limited subset of the test cases or no tests at all.
All changes to controlled documentation are subject to Change Control per SOP Document and Data Control.
The potential impact on regulatory approvals or the need for additional clinical data must also be reviewed to determine if submission to regulatory agencies is required.
Design Changes shall:
§ Ensure that all the elements of the Design Control are considered for potential impact.
§ Design and Development Planning
§ Design Inputs [Market Specification and Product Specification]
§ Risk Analysis
§ Design Outputs
§ Design Verification
§ Design Validation
§ Design Reviews
§ Be documented in the Project PDP Design History File and in the Change Control documentation.
Design Change Post Design Transfer Design Review:
Design changes to products where Design Transfer Design Review is complete are conducted in accordance with Design Change SOP.
The guiding principal of this policy is that the level of documentation and evaluation should be in direct proportion to the significance of the design change based upon a risk analysis review.
§ Design Changes shall include a Proposal step initiating the change.
§ A Regulatory Assessment shall be conducted to determine impact of existing approvals in all regions where product is marketed.
Design Changes shall:
§ Ensure that all the elements ofthe Design Control are considered for potential impact.
§ Design and Development Planning
§ Design Inputs [Market Specification and Product Specification]
§ Risk Management deliverables
§ Design Outputs
§ Design Verification
§ Design Validation
§ Design Reviews
§ Design Transfer[Including Process Validation]
§ Be documented utilizing the Design History File Design Change Log for the project, and the Change Request (CR) using a Change Analysis Form.
Ensure all applicable elements of Design Control are satisfied prior to implementation of the design changes.
Design History File & Design Control Record Retention
The following is an overview of records that are created as a result of this policy and comprise the Design History File—their locations and retention times are per any site Design History File/Record Retention procedures:
· Design and Development Planning
- Scaling Plan
- Project Contract
· Design Input
- Market Specification
- Product Specification
· Risk Analysis
– Product Risk Analysis
– Use FMEA
– Design FMEA
– Risk Management Report
– Process FMEA
– Clinical Risk/Benefit Analysis
· Design Verification and Validation
- Design Verification plans, protocols, and reports
- Design Validation plans, protocols, and reports
· Design Transfer
- Design Review Reports- Design Transfer
- Process Master Validation plans, protocols, and reports
- Quality Plan
· Design Review
– Design Review Reports-Product Specification
– Design Review Reports-Design Freeze
– Design Review Reports-Design Verification
– Design Review Reports- First Human Use
– Design Review Reports- Design Transfer
– Action items and closure documentation
· Design Output
- Domestic and International Regulatory Submissions
- Device Master Record (DMR)
The DHF for the project shall reference or include all documents to meet the requirements as outlined above. Each product design/PDP project will have a unique project number and associated Design History File. If more than one device shares elements of a Design History File, reference to documents or document location shall be included in the Design History File for each project.
Now when it comes to your software for the above elector-mechanical system.
For the software you require to do the following:
Usually the requirements for compliance with 21 CFR Part 11 GAMP 5 for computer systems involves the developments of the outlined below documents and the operation of the validated computer systems per the approved procedures which will provide evidence that the computer/software system at locality are in compliance with the regulatory bodies (FDA/EMA/HC) requirements.
You might have different requirements then the ones outlined below for computer validation, it is up to you to specify exactly what is required so you may attack the solution in a timely matter.
This guide will reference: *(CS) Computer System
1) SOP-IT-001-CS-Risk Assessment.
2) SOP-IT-002-CS-Users Requirements Specification Development
3) SOP-IT-003-CS-Supplier Vendor Assessment and Audit.
4) SOP-IT-004-CS-Validation Master Plan Development.
5) SOP-IT-005-CS-Functional Specification Development.
6) SOP-IT-006-CS-Design Specification Development.
7) SOP-IT-007-CS-Installation Qualification Development. (You require this for test scripting of your software)
8) SOP-IT-008-CS-Operation Qualification Development. (You require this for test scripting of your software)
9) SOP-IT-009-CS-Performance Qualification Development. (You require this for test scripting of your software)
10) SOP-IT-010-CS-Validation Summary Report Development.
11) SOP-IT-011-CS-Traceability Matrix Development.
Form-IT-011.01-CS-Traceability Matrix Development Form.
12) SOP-IT-012-CS-Validation and Use of Excel Spreadsheets.
Form-IT-012.01-CS-Validated Excel Spreadsheet Access List.
Form-IT-012.02-CS-Excel Spreadsheet Validation Protocol Form.
Form-IT-012.03-CS-Excel Spreadsheet Validation Test Form.
Form-IT-012.04-CS-Excel Spreadsheet Validation Statement Form.
13) SOP-IT-013-CS-Problem Management and Resolution
14) SOP-IT-014-CS-Back-Up and Recovery
Form-IT-014.01-CS-Back-Up Log Form
Form-IT-014.02-CS-Back-Up Request Form
Form-IT-014.03-CS-Recovery Request
15) SOP-IT-015-CS-Configuration Management
Form-IT-015.01-CS-Instllation and Configuration Request Form
16) SOP-IT-016-CS-Performance Monitoring
Form-IT-016.01-CS-Performance Monitoring List
Form-IT-016.02-CS-Performance Monitoring Log
17) SOP-IT-017-CS-Security and Access Management
18) IQ/OQ/PQ Test Scripting Plan Template Document
Hopefully I have answered your question. If you had somebody that knows how to navigate through these requirements, you are looking a full time position for 18 months to reach finalization.
Good luck.
LUCK= Laboring Under Constant Knowledge.
  • asked a question related to Medical Devices
Question
5 answers
What criteria is required for designating a medical device as a 'custom device'? Does an IRB need to review the use of a 'custom device'?
Relevant answer
Answer
Application specific
  • asked a question related to Medical Devices
Question
2 answers
We are conducting acute toxicity studies with our medical device that formulated with LRS. This a required test to demonstrate bio-compatibility of the medical device.Typically they inject an extract of the device .The extract can be oil and saline.The extract from is administered IP
Relevant answer
Answer
Varun
Thank you very much. If anyone would know is Dr Gad.
  • asked a question related to Medical Devices
Question
2 answers
Dear all, I am looking for a safe screw lubricant that could apply on the medical implant and device production unit that work around 160oC to 500oC. I have found some PFPE, synthetic hydrocarbon and Silicone base lubricant for only medical device but not the production unit.
I wonder is there any specific lubricant for the medical implant and device production machine that could use under high temperature. Have anyone study about it?
  • asked a question related to Medical Devices
Question
4 answers
EEG (Electroencephalogram) is a technique for recording electrical activity of brain. Traditionally Ag/AgCl, Ag, Stainless Steel are used as the electrode material. Can copper be used for dry EEG electrodes ?
Relevant answer
Answer
I am afraid copper would start to electrochemically interact with the skin (not really dry - especially after cleaning it from fat to lower the impedance) very soon (minutes) which would change the impedance of your setup or even introduce a potential like a battery (skin pH<>0). Ag/AgCl in combination with a NaCl gel remains very stable during the period of EEG measurement.
  • asked a question related to Medical Devices
Question
4 answers
I am conducting a study evaluating risk for pressure injuries among critical care patients. I have EHR data pertaining to moisture, nursing skin assessments, body temperature, and also medical devices for surgical critical care patients. I would like to find a way to indirectly assess micro-climate.
Relevant answer
Answer
Dear Jenny
I'm studying skin microclimate in Brazil and the relationship with the pressure injuries development.
You may send me a private message.
KR
  • asked a question related to Medical Devices
Question
1 answer
I need a reference for the "pre-clinical testing market for vascular implantable devices (including peripheral stents, angioplasty tools, aortic stents, synthetic surgical grafts, chronic total occlusion devices, embolic protection devices and inferior vena cava filters)"
In Dollars or Euros and for U.S.A, Europe, or worldwide.
Relevant answer
Answer
I follow the question.
  • asked a question related to Medical Devices
Question
6 answers
Which are the prominent companies in India capable of medical device industrial design support?
Looking to outsource ergonomics, user centric, human factor design support works of our medical devices under development.
If anybody there, please mention your capabilities.
Relevant answer
Answer
I am an Industrial Designer with specialization in Product Design and Development. I have been studying a Master in Design for Health at OCAD University since September. I can help you.
  If you want, please contact me.
my E-mail is gerscharum@gmail.com
I'm looking forward to hearing from you
German
  • asked a question related to Medical Devices
Question
3 answers
Most laws in Great Britain, Canada, Australia, and the United States have been interpreted as including a "patients right not to want to be told the risks of the medical treatment recommended by his or her physician. Should there be an "opt out clause" in research informed consent so that the individual can volunteer for a research trial for a new drug or new medical device without being told of the risks by the researcher, research team, or informed consent? Is this "opt out clause" in clinical care vs. research on human subjects a "good idea" of a "bad idea"? Why? On what grounds?
Relevant answer
Answer
The doctrine of patient autonomy, one of the principalist medical ethics suggests that there would be a right "not to know".
The rather difficult problem is what it is they would not know. Since all current medical law and treaties require the consent of all research subjects in clinical trials they would need to be informed before consent could be given.
  • asked a question related to Medical Devices
Question
6 answers
TACS is a device that imports frequencies to your brain in order to persuade your brain’s neurons oscillate by them.
Is it possible to enhance the skills of people with usual intelligence and make them smart by importing gamma ray to their brain?
Does the mechanism have long lasting effects?
Have you ever read something about it?
Relevant answer
Yes, such as periodic modulation of excitability, shifts in spike timing, modulation of firing rate, and shifts in the balance of excitation and inhibition.
  • asked a question related to Medical Devices
Question
3 answers
Cell Constraint & Cancer SA
Proof of Concept in 2014: Action of mechanical Cues in vivo on the Growth of a subcutaneously grafted Tumor (Published 21 April 2016, PloS One, R Brossel et al). 
Next Step: Proof of Efficacy on orthotopic Graft of Human Pancreatic Cancer in Pancreas of Mice
Combination of two medical devices: A generator of gradient of magnetic field and iron nanoparticles.
We are looking for Partners in the academic and industrial world; We are looking for investors.
Cell Constraint & Cancer (CC & C) is a start-up of biotechnology in support of R&D of a new approach in cancer research. The disruptive innovation (Patent PCT/EP 2014 064995), involves the application of mechanical cues (constraint/stress field) in the treatment of cancer. Physical Oncology defined as the study of cancer tissue with the tools of the solid matter physics is trying to subvert our concept of cancerous tumors.
The demonstration of Proof of Efficacy of this process would consider a crossing to humans by the year 2020. Right now we have begun a feasibility study of Proof of Efficacy, biological as well as physical. Proof of Efficacy itself is planed in Q4, 2016.
CC & C is presently “burning cash”, and is a bet on a success realized by a co-development with a company manufacturer of gradient of magnetic field equipment and/or a pharmaceutical company familiar with injectable ferric nanoparticles.
Relevant answer
Answer
Nice thought!!
I don’t know if i am right but i am wondering if yoga therapy does the same.
The important contribution from mechanobiology i feel could be along with chemical cues.
if only drug does not respond to certain pathology, we can make mechanical therapy as synergistic effect.
Its my personal opinion but it is worth trying
  • asked a question related to Medical Devices
Question
1 answer
HbA1c estimation using boronate affinity method requires a blue dye conjugated Boronic acid. I would like to procure one or two commercially available molecules. Please suggest me one or more.
Thank you
Relevant answer
  • asked a question related to Medical Devices
Question
8 answers
We develop medical devices for characterization of thin tissues which should be produced from plastic/polymers (wall thickness <1 mm ~ 0.5 mm). The devices should be suitable for light microscopy, in the ideal case with a refractive index close to water (which is ca. 1.33 @ 500 nm).
Are there any lists, books or publications with transparent polymers where I can also find the refractive index of the material? Polymers suitable for medical use would be best.
I checked refractiveindex.info but there is a limited amount of polymers. I thought about standard mass production polymers such as PMMA, PS, PP, PE, PET, PC... but also any other transparent polymers!!
Thank you very much!
Relevant answer
Answer
Here is a list:
Most of the polymers with lower RI are fluorinated.
  • asked a question related to Medical Devices
Question
3 answers
An exciting opportunity has become available to work full time on a 3-year project to design and develop a smart technology for real-time alarm and remote monitoring system implementation on medical devices. This is a partnership between Manchester Metropolitan University and Pure O2 Ltd, funded by Innovate UK.
Apply for the job here at
You should have high level of expertise in analogue/digital circuits design and simulation and skills to develop electronic hardware in general with experience in embedded systems.
For an informal discussion, please contact Dr Rupak Kharel (r.kharel@mmu.ac.uk)
Please share this within your network who might be interested on it.
Relevant answer
Answer
Can this project implemented as a PhD project under your supervision?
  • asked a question related to Medical Devices
Question
7 answers
Dear all,
legal framework regulating application of Articial Intelligence Medical Devices differs in Europe and the United States.
Furthermore, the issues of legal accountability the ethical responsibility that AI applications imply all over the world are worthy of discussion on RG. This because the process of medical devices decision-making is largely unpredictable, therefore holding the creators accountable for it clearly raises concerns.
I would like to ask yours opinion about the role of radiologists in the development and application of AI to medical imaging.
Thanks to everybody!
Filippo
Relevant answer
Answer
For example, short and long-term distance, short and long -term memory.
  • asked a question related to Medical Devices
Question
1 answer
Cyber-physical systems (CPS) link cyberspace with the physical world through a network of interrelated elements, such as sensors and actuators, robotics, and computational engines. These systems are highly automated, intelligent, and collaborative. CPS examples include energy neutral buildings, zero-fatality highways, and personalized medical devices.
Parallel system (PS) methods are further development and natural extension of control systems and computer—based modeling and simulation,resulting from new and recent advances in computing structure, algorithms, and technology.Parallel system methods might provide effective tools for control and management of complex systems that can not be modeled precisely or experimented repeatedly.
Relevant answer
Answer
I think CPS is different from Parallel system. Parallel system normally for simultaneous tasks, especially computation, i.e. parallel computing. Parallel computing is used for high performance computing.
CPS on the other hand is bringing together physical system into the cyber space with the help of various emerging and enabling technologies. This is especially for realizing smart systems and infrastructures, autonomous systems, etc. Parallel system may be just a drop in the ocean of CPS.
  • asked a question related to Medical Devices
Question
3 answers
The carotid shunt is made up of a tube on the extremities of which the balloons are glued during the manufacturing process. Quality control (functionality test) are carried out in order to ensure that the product is conform. It has to be ensured that the balloons suffer no leaks.
What are the possible quality control test (non-destructive) that can be put in place after the assembly process to ensure conformity of the product ?
Relevant answer
Answer
I tend to agree with Dr. Garry. During manufacture every 10th product should be tested by a competent technician, inflating the balloons to the recommended volume and seeing that they hold the air for a few hours.
Prior to actual use in surgery, the surgeon should make sure that he/she repeats the testing. Only this time it will only be for a few minutes. And it always pays to have a back-up Pruitt-Inahara shunt in the room.
  • asked a question related to Medical Devices
Question
2 answers
What are the problems encountered with carotid shunts that are used in carotid endarterectomy and their possible solutions?
Relevant answer
Answer
The answer above is incorrect....firstly the overall flow through a carotid shunt is quite small,and secondly,it is only performing the job of the native artery,bypassing it whilst the carotid is clamped and operated upon.
The real issues with carotid shunts are as follows:
1.Decision making process in inserting a shunt may take time,and in some cases may be incorrect,thus relying on good perioperative techniques for measuring or quantifying adequate cerebral blood flow such as TCD and INVOS.
2.Inserting the shunt into the carotid artery can result in dislodging plaque material distally during insertion,or occasionally dissection.
3.The shunt can be placed too far down into the common carotid,and may enter the subclavian origin and occlude flow to the arm,or lose flow through the shunt.
4.The shunt can be dislodged or blown out of the artery,neccesitating reclamping and replacement,with all of the above risk factors.
5.The shunt can interfere with visualising the operation site and may impede surgery to a small degree.
In short,if there is a lack of adequate monitoring of cerebral perfusion,a shunt can be thought of as mandatory by many,but if there is reliable and validated cerebral monitoring(such as INVOS or TCD),then shunting should only be performed where indicated.
Hope that helps.
  • asked a question related to Medical Devices
Question
2 answers
What are common autoclavable materials other that Stainless steel that can be used for medical devices like scalpel.
Relevant answer
Answer
Besides stainless steel, many materials and instruments made of titanium alloys are used in medical technology. Also, corrosion resistant nickel and cobalt base alloys such as, for example, vitallium (CoCrMo) are among medical materials.
  • asked a question related to Medical Devices
Question
3 answers
Dear colleagues.
Would you be kind to recommend me some guidance or study which gives an information regarding the resistance of common organisms (found in the environment or normal flora of the skin) to EtO sterilization?
I am asking in terms of medical device application. Thank you in advance.
Relevant answer
Answer
Thank you very much.
I will check it out.
Have a nice weekend.
  • asked a question related to Medical Devices
Question
6 answers
Drug companies and medical devices industries provide financial support to clinical researchers, to medical meetings and also provide direct and personal support to physicians paying their travell expenses. How do you criticize those financial relations among health care industries and doctors? Are they ethical ? Should they be cancelled? Drug Advertising or Marketing of drugs should be forbidden? Do they influence clinical decisions and research results?
Relevant answer
Answer
Pharmaceutical promotional activities take many forms, including provision of samples, face‐to‐face meetings between industry representatives and prescribers, advertising in print and electronic media, and support for meetings and travel. There are a number of studies which report that the amount spent by pharmaceutical companies on promotional activities exceeds the amount spent on research and development of new drugs.
See, for example, a free-access paper by Komesaroff PA: “Ethical issues associated with gifts provided to physicians by the pharmaceutical industry” (available at doi:10.1111/j.1445-5994.2010.02215.x) published in the Internal Medicine Journal in 2010. It is a useful source of information on the influence that pharmaceutical companies have on clinicians. The author argues that “The concern is not merely that the evidence shows that all promotional activities influence prescribing behaviour (contrary to the protestations of many physicians) .… What is [also] of concern is the possible impact of this influence on both the form and content of healthcare delivery.” The paper also has many useful references.
One of these references, a pay-to-view paper by Wazana A: “Physicians and the pharmaceutical industry: Is a gift ever just a gift?” published in JAMA in 2000 (available at doi:10.1001/jama.283.3.373), the author notes that: “Meetings with pharmaceutical representatives were associated with requests by physicians for adding the drugs to the hospital formulary and changes in prescribing practice. Drug company–sponsored continuing medical education (CME) preferentially highlighted the sponsor's drug(s) compared with other CME programs. Attending sponsored CME events and accepting funding for travel or lodging for educational symposia were associated with increased prescription rates of the sponsor's medication. Attending presentations given by pharmaceutical representative speakers was also associated with nonrational prescribing.”
A pay-to-view paper by Greenway T & Ross JR published in The BMJ in 2017, titled “US drug marketing: how does promotion correspond with health value” (available at doi.org/10.1136/bmj.j1855) assesses the effectiveness, usefulness, and affordability of the drugs that get the heaviest promotion. This article also has useful references.
A free-access article by De Ferrari A, Gentille C et al., published in PLoS in 2014, titled “Attitudes and Relationship between Physicians and the Pharmaceutical Industry in a Public General Hospital in Lima, Peru” (available at doi: 10.1371/journal.pone.0100114) presents a study described as being in a undertaken in a resource-poor setting, “where a close relationship between physicians and industry still exists”.
This De Ferrari et al. paper also summarises a number of earlier studies as follows: The interaction between physicians and the pharmaceutical representatives adversely influences doctors’ behaviour and knowledge. There is a tendency for non-rational prescribing, more favourable attitudes towards industry representatives, preference for newer, more expensive drugs and an inability to identify incorrect claims about medications. Moreover, this effect on doctors’ behaviour and knowledge is dose-dependent: frequent contacts and acceptance of gifts (independent of the gift's value) imposes a need to reciprocate that affects medical judgment.
  • asked a question related to Medical Devices
Question
23 answers
Glue is discharged from a syringe tip at a constant pressure P through a constant time period t.
The original tip is of diameter d1= 0.20 mm. A new tip is used of diameter d2 = 0.25 mm.
Considering only the tip of the syringe i.e. constant length and constant diameter, does the flow rate (be it mass flow rate or volumetric flow rate) decrease with the new tip for P and t ?
Relevant answer
Answer
For an increased diameter and constant pressure, the volume flow of your fluid should be increased significantly. This is actually quite easy to calculate for newtonian fluids. However, as you describe your fluid as "glue", it may have all sorts of strange properties.
  • asked a question related to Medical Devices
Question
3 answers
Good morning every one,
Can you help me?
I work on medical device failures ratio. I am searching any open source databases (csv, Access base or others) with a web access.
It will very interesting to obtain device classification informations by medical services (radiology, pediatry, ...), failure dates, hospital or clinical name, country, device and maintenance costs,...
Do you know somme website?
Thank you.
Relevant answer
Answer
The offical USFDA and WHO Websites have a lot of Information about medical devices.
As quoted in the previous answer MAUDE is a free high volume database
  • asked a question related to Medical Devices
Question
3 answers
Biofilm formation on medical devices is one of the important problems now due to difficulty of its removal and the complicated microbial infections as well as the decreasing of the effective of antibiotics and disinfectants.
Relevant answer
Answer
The most effective way is to find materials that inhibit the adherance of bacterial on medical device surfaces and prevent biofilm formation .
  • asked a question related to Medical Devices
Question
4 answers
Hello,
Does anyone have this standard:
ISO 10993-12:2012
Biological evaluation of medical devices — Part 12: Sample preparation and reference material
??
Can you please send a copy?
Thank you very much
Best
Relevant answer
Answer
Interlibrary loan, maybe. Prêt interbibliothèque, peut-être.
  • asked a question related to Medical Devices
Question
6 answers
Iridology (also known as iridodiagnosis or iridiagnosis) is an alternative medicine technique whose proponents claim that patterns, colors, and other characteristics of the iris can be examined to determine information about a patient's systemic health.
Now I want to know what medical devices can be used for this process so we can save photos and process them?
Relevant answer
Answer
I thought pseudoscience questions belonged to other forums...
  • asked a question related to Medical Devices
Question
2 answers
Do you know some cheap hydrogel to cover the surface of medical devices?
Relevant answer
Answer
i follow
  • asked a question related to Medical Devices
Question
3 answers
Nutrition related diseases are nowadays a main threat to human health and pose great challenges to medical care . A crucial step to solve the problems is to monitor a daily food intake of a person precisely and conveniently . Can use a wearable device to monitor and recognize food intakes in daily life ?
Relevant answer
Answer
As for as my personal experience is concerned, couldn't benefited by this technique.
  • asked a question related to Medical Devices
Question
3 answers
Electronic Fetal Heart Monitoring can be done by listening to your baby's heartbeat with a special stethoscope. More often, it is done using two flat devices (sensors). They are held in place with elastic belts on your belly. One sensor uses reflected sound waves (ultrasound) to keep track of your baby's heart rate. The other sensor measures how long your contractions last. The sensors are connected to a machine that records the details . can the phone be used for recording this signal?
Relevant answer
  • asked a question related to Medical Devices
Question
1 answer
Prior to the actual training of movement in rehabilitation with a medical device, it is often necessary to introduce the exercise and the way the device and/or the training software (program) works, and how the feedback and the movement are tied together. But how can you define the threshold for: the patient has understood the task and is now ready to proceed to the actual training (with less or no assistance). What are feasable markers or parameters (e.g., time to achieve a goal, number of successful repetitions, etc.)? And how can you best show and teach the exercise?
Relevant answer
Answer
Correct Techniques, in line with gold standards. When people will be ready to control velocity, force and direction they are ready to come back to they life.
In order:
1) A bit of strength (Force impovement)
2) Movement velocity (total control)
3) Movement Directions (Be able to fully control the body segment)
In my view these are 3 important sign that the neuromuscular system is ready to come back to the normal life.
  • asked a question related to Medical Devices
Question
5 answers
Microorganisms that grow on medical devices form biofilms. Normally, biofilms protect the cells from the animicrobial activity of chemical biocides (including surfactants) and antibiotics. The question is how to destroy or prevent biofilm formation on medical devices?
Relevant answer
Answer
Following Article helpful to you. It includes all of novel methods to remove of Biofilms in anywhere. Please read it. You will able to remove biofilm from your device.
Thank you.
  • asked a question related to Medical Devices
Question
3 answers
Sometimes the one who's injured may not be be able to talk and score his pain. for several medical actions the intensity of pain and it's position is required. I've been told using fMRI somehow helps, yet I'm wondering how and I would like to know if there's any more accurate device to measure pain intensity.
Relevant answer
Answer
Pain is a very delicate matter, in general, it is a neurological transmission which is interpretation is "pain". One can use electro-measurement devices detect the intensity of the transmission of the "pain". However, it will not tell you "how much it hurts" for different people can both tolerate different levels of pain, and the feeling of pain may vary by subjecting the people to different chemicals (natural or artificial).
  • asked a question related to Medical Devices
Question
6 answers
- Could you please point me out to some successful Medical sciences applications using partial differential equations?
- Preferably, involving heat, reaction-diffusion, Poisson, or Wave equation.
- If possible in fuzzy environment.
Best regards
Sarmad.
Relevant answer
Answer
Dear Professor, In mathematical modelling for drug delivery we are using PDE.
  • asked a question related to Medical Devices
Question
6 answers
I did a test on a set of subjects (n=28) two times with a medical device. I believe it is kind of intra rater measurement (ICC(3,1)). Could you please tell me if I am right? On the other hand I want to use one normally distributed plot for these two groups. Can I use the mean value for each subject (I did the experiment two times on each subject) then plot it?