Content
For every manufacturer who develops, manufactures, packages, sterilizes, stores medical devices for the US market or carries out any other activity in the life cycle of a medical device on the industrial and commercial side, 21 CFR 820 applies. The American regulations for There is a lot of overlap in quality management with DIN EN ISO 13485 - but the differences should also be taken into account.
In this seminar, the contents of 21 CFR 820 are presented in a compact manner. But true to the motto “theory for practice”, the participants are shown examples of how they can best apply the content of the American regulations.
Topic overview
- Structure of 21 CFR 820
- Comparison 21 CFR 820 with DIN EN ISO 13485
- Development of a QM system based on DIN EN ISO 13485 and 21 CFR 820 as a supplement
- What additional requirements must be met if a QM system according to DIN EN ISO 13485 already exists?
target group
Manufacturers who are already present in the USA or are planning to enter the market or want to prepare for an FDA inspection.
Prior knowledge
Knowledge of DIN EN ISO 13485 and its application is an advantage.
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
