Post-Market Surveillance
Post-Market Surveillance (PMS) refers to a proactive and systematic process within the quality management system aimed at drawing the necessary conclusions from information about the quality, performance, and safety of a medical device that has already been placed on the market, and implementing any required preventive or corrective actions.
With the MDR/IVDR, significantly greater emphasis is placed on post-market surveillance. However, all other relevant regulatory frameworks, 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.
The seminar contents
Requirements for post-market surveillance (PMS):
- Requirements under the MDR / IVDR (manufacturer’s system for post-market surveillance, including 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
Costs
1 day in-house training: Euro 3.790,- (excl. VAT) for max. 10 participants; incl. seminar documents and certificate of attendance, plus travel expenses.
your trainer
DI Martin Schmid, Managing Director & Senior Consultant en.co.tec
Information about our trainers
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
