After the transition periods have expired, all manufacturers, distributors, EU authorized representatives and importers of medical devices must comply with the requirements of the MDR.
During this training you will learn which requirements you and your company need to know, understand and fulfill.
Seminar contents
This seminar thus provides you not only with comprehensive knowledge, but also with the skills to revise your quality management system, in particular your processes and specification documents, in order to develop medical devices in conformity with MDR, to bring them to market and to monitor them there. This 1-day version of the seminar also focuses on the differences to the old EU directives. If you would like an even more comprehensive overview, we recommend our 2-day variant with a large practical part.
Here you will find more information about the next dates, costs and registration. If nothing else is noted in the table on the overview page, there are still free places.
Time | Topic focus |
---|---|
09:00 | Beginning of the seminar |
09:00 | Expectations, introduction |
09:30 | Background, regulatory map, changes at a glance |
10:00 | Actors and roles |
10:30 | Break |
10:45 | Classification and conformity assessment |
11:30 | Safety and performance requirements, technical documentation, “common specifications” and harmonized standards |
12:30 | Lunch |
13:30 | UDI, EUDAMED, Registration |
14:15 | Post-Market Clinical Follow-Up (PMCF), clinical evaluation, clinical trial (upon request). |
15:00 | Break |
15:15 | Post-Market Surveillance PMS, Vigilance |
16:00 | Quality management |
16:30 | Other, open questions |
17:15 | End of the seminar |
We limit the number to a maximum of 16 participants to ensure learning success and to have enough time to answer individual questions.
The seminar is intended for persons involved in the development of medical devices in compliance with standards, in particular for
The seminar is also suitable for beginners and people who "only" want to get an overview of MDR. However, depending on the expectations of the participants, the seminar leader will address the specific questions in detail.