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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Training course / seminars

This course can be modified to reflect your product and company. It can be held at customer site or online.

Price depends on the overall arrangement for your customized course. An offer will be submitted based on your request.

More about our customized training courses and seminars

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