Content
DIN EN ISO 13485 is well known in the medical device world. After all, it is already the basis for the certification of medical devices according to the EC guidelines and other regulatory systems worldwide. However, the new regulation has defined additional quality management requirements that must be taken into account in the course of the EU MDR.
This seminar explains the differences between DIN EN ISO 13485 and the EU MDR requirements and what specifically needs to be taken into account.
Topic overview
- What legal and normative bases and requirements are there?
- Who needs a quality management system according to EU-MDR?
- What are the key points of an EU MDR-compliant quality management system?
- What must be specified in addition to DIN EN ISO 13485?
target group
This seminar is intended for everyone involved in the development of an EU MDR-compliant quality management system.
Prior knowledge
Good knowledge of DIN EN ISO 13485 is required.
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
