content
21 CFR 820 applies to every manufacturer who develops, manufactures, packages, sterilizes and stores medical devices for the US market or carries out any other activity in the life cycle of a medical device on the part of industry and trade quality management, there is a lot of overlap with EN ISO 13485:2016 - but the differences should definitely be taken into account.
In this seminar, the contents of 21 CFR 820 are presented in compact form. But also true to the motto "Theory for practice", the participants are shown examples of how they can best apply the contents of the American set of rules.
topic overview
- Structure of 21 CFR 820
- Comparison of 21 CFR 820 with EN ISO 13485:2016
- Development of a QM system based on EN ISO 13485 and 21 CFR 820 as a supplement
- What additional requirements must be met if a QM system according to EN ISO 13485:2016 already exists?
target group
Manufacturers who are already represented in the USA or are planning to enter the market or would like to prepare for an FDA inspection.
previous knowledge
Knowledge of EN ISO 13485:2016 and its application is an advantage.
KONTAKT:
Online
