Post-Market Surveillance for medical device industries in the EU: responsibilities and obligations

This presentation, dedicated to the certification seminar course for Medical Device Regulation (MDR), is titled “Post-Market Surveillance for medical device industries in the EU: responsibilities and obligations”. In the course, the participants become familiar with the responsibilities and obligations of the manufacturer in the implementation of Post-Market Surveillance in medical device industries according to the new MDR. This web-based training provides a summary of these responsibilities.
Learning goals
The participants know and understand…
1. … what PMS is and the obligations for a manufacturer of medical devices
2. … how a PMS plan shall be developed
3. … the connection between Risk Management, Quality Management and PMS