The webinar provides an overview on the requirements laid down by the new Medical Device Regulation (MDR) with a focus on medical device software. These requirements will become effective in May 2020. For class I devices (most software products fall into this class), there is no transition period. The new classification of standalone software such as apps increases the regulatory requirements even more.
Startups, SMEs, Companies that develop medical software
- new requirements of the MDR for medical devices software
- how to achieve compliance with MDR
- how to get support for Quality Management System and Technical Documentation
Prof. Dr. Christian Johner is the founder and owner of the Johner Institute (www.johner-institut.de/). He is passionate about software development, medicine, quality management and teaching. Together with his team, he consults hundreds medical device manufacturers in Europe and in the USA. Christian Johner is auditor and member of IEC 62366 standards committee. He publishes weekly articles that have several 10.000 readers.
As a professor, Christian Johner teaches or taught software architecture, software engineering, software quality management and biomedical informatics at several universities e.g. in Konstanz, Krems, St. Gallen, Würzburg and Stanford.
The master study courses, seminars, and e-learning trainings are joined by almost all well-known medical device manufacturers and hospital chains.