Content
The seminar will provide an overview of the post-market surveillance (PMS) plans and reports, the systematic collection of post-market clinical data (PMCF) and the regularly updated safety report (Periodic Safety Update Report = PSUR). It includes the contents of the plans/reports and answers the question of what sources they should come from.
Dependencies between the risk class and the update intervals of the reports as well as cross-connections to other documents are shown. In particular, participants will be informed about the new requirements under the EU MDR.
Topic overview
- Overview of plans and reports (PMS/PMCF/PSUR)
- Content/sources (technical documentation and others)
- Dependencies on the risk class/update intervals
- Dependencies on and cross-connections to other documents
- New requirements under the EU MDR
target group
Employees from the areas of clinical and regulatory affairs, product management, business development, project managers, consultants, service providers for medical devices, authorities.
Prior knowledge
Knowledge of the EU MDR is recommended.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Online
