Description
This seminar will be held in German!
Post-Market Surveillance (PMS) is a proactive and systematic process in the quality management system to draw the necessary conclusions from information about the quality, performance and safety of a medical device that has already been placed on the market and to implement any preventive or corrective actions.
With the MDR/IVDR, there is a much stronger focus on post-market surveillance. However, all other relevant regulations such as ISO 13485:2016 and ISO 14971:2019 also require post-market surveillance.
This seminar provides an overview of the current regulatory requirements on these important topics.
Seminar contents
Post-market surveillance requirements:
- Requirements from MDR / IVDR (manufacturer’s system for post-market surveillance (incl. PSUR):
– Post-market surveillance plan
– Technical documentation on post-market surveillance - Requirements from ISO 13485:2016 Quality management for medical devices
- Requirements from ISO 14971:2019 Risk management for medical devices
- Requirements from ISO/TR 20416:2020-07
- Exercise examples
Date
12.12.2025 from 9:00 to 16:30
Participants
This seminar is not suitable for participants without prior knowledge. Basic knowledge of the MDR and IVDR is recommended.
Your trainer
DI Martin Schmid, Managing Director & Senior Consultant, en.co.tec Schmid KG
Costs
- Early booking (up to 4 weeks before the seminar): Euro 540,- (excl. VAT)
- Standard (from 4 weeks before the seminar): Euro 610,- (excl. VAT)
- incl. seminar documents as PDF and a confirmation of participation
- All seminar discounts at a glance
Venue: ONLINE
