Quality management requirements in the USA
The US market is one of the most important global markets for medical products. All medical devices that are to be sold in the USA must meet the strict requirements of the US Food and Drug Administration (FDA).
In this seminar, you will learn about the quality management standards according to 21 CFR 820 of the FDA as a prerequisite for the successful market access of your medical devices in the USA as well as the differences to ISO 13485:2016. Our USA expert will show you how to design your QM system so that all the different requirements are met and you successfully pass FDA inspections.
The seminar contents
- Quality management requirements USA 21CFR 82
- Overview and definitions
- Requirements for the QMS
- Procedure of an FDA inspection
- Possible effects of an FDA inspection
- Similarities and differences between 21CFR 820 and the
- requirements of the EU MDR 2017/745
Your trainer
Cornelia Luban, Senior Consultant, Qserve Group Deutschland GmbH
Information about our trainers
Costs
1 day in-house training: Euro 3.790,- (excl. VAT) for max. 10 participants; incl. seminar documents and certificate of attendance, plus travel expenses.
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
