Quality System Regulation, 21CFR820

1-day course

The objective of the course is to create a basic understanding for the regulatory and quality framework surrounding a Medical device or an In-Vitro Diagnostic device in USA. 

The course will cover main topics in the Quality System Regulation, recognized standards, design control and risk management of a medical device. 

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Dates and location

To be planned

To be planned

Online course
To be planned

1-day course: SEK 7 750:-
Group registration*

All prices excl. local VAT.

*For group registrations, the 2nd and 3rd persons from the same company will receive a 10% discount. For 4th and additional persons, a 20% discount will be applied.

Customized training courses and seminars

We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.