Maciej Piwowarczyk vel Dabrowski’s research while affiliated with University of Rostock and other places

A multitude of regulations and the lack of established best practices make the market launch of ICT-based medical devices in Europe very complex. This paper is part of a project aiming at methodical support for medical device launch. Its goal is to investigate a management system for regulative compliance of ICT based medical devices. To understand the requirements for medical device manufacturers the regulative and normative foundation of market launch of ICT based medical device were analyzed and the necessary processes and requirements of a quality management system (QMS) according to ISO 13485:2016 were matched towards enterprise architecture (EA). ISO 13485 was chosen as this standard is required by law for most common ways of medical devices launch. The main contributions of our work are: (a) a literature analysis of requirements for ICT based medical device manufacturers; (b) integrating requirements of an ISO 13485 QMS and the medical device market launch in an EA model; and (c) showing that fulfilling the ISO 13485 requirements is not enough and there are much more normative and regulative requirements.

The market launch and regulative assessment of ICT-based medical devices in Europe is very complex due to a multitude of regulations to be considered during requirements engineering and product management. Additionally, there are no established standards, best practices or support tools how to launch medical devices on the market. The paper is part of a project aiming for methodical support for medical device launch and assessment, and is dedicated to investigating problem relevance. To understand the processes and requirements three case studies were analysed and the necessary processes and requirements were matched towards enterprise architectures (EA). Based on this finding, we argue that EA could be a suitable way to visualize and recommend required processes and structures for medical device management. The main contributions of our work are (a) a literature analysis of EA use in health care and especially for telemedicine, (b) results from use case analysis investigating the business perspective from inside three health tech companies and (c) the analysis of problems of telemedicine integration into EA.