Quality Management

Successful introduction of innovative approaches onto the market requires adherence to specific regulations, such as the German Act on Medical Devices (MPG) or the approval guidelines of the United States Food and Drug Administration (FDA).

Fraunhofer MEVIS is one of a small group of research facilities that, in Bremen since 2005 and in Lübeck since 2012, has operated a quality management system according to the EN ISO 13485 (Medical Devices) standard with a special focus on implementing a software development process in compliance with IEC 62304.

The establishment of these quality management systems with the scope on design, development and production of software for medical products lays out well-defined steps for industrial cooperation and enables Fraunhofer MEVIS to provide market-ready solutions for commercial partners in the strongly regulated medical device market.

In addition, Fraunhofer MEVIS also has experience with CE and FDA approval of software solutions for clinical environments.