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.