QSReg Medical Devices USA

Current Good Manufacturing Practice – FDA, USA 21 CFR part 820 Quality System Regulation

Course length
1 day

Each day 08:30 – 16:30 (8.30 a.m. – 4.30 p.m.)





For marketing of medical devices in USA, each manufacturer must comply with the requirements of 21 CFR 820 (Quality System Requirements) during the development, manufacturing, quality control and distribution processes.
Scope Participants will get detailed knowledge about the requirements of 21 CFR 820 QSR
Intended for



The course is intended for managers and supervisors in executive management, product development, sales and marketing, manufacturing, quality control, distribution, service and any other function being involved with the FDA requirements for medical devices and diagnostic products.









  • Background for regulatory requirements for medical devices
  • Getting a new medical device to the US market
  • Food and Drug Administration (FDA)
  • FDA Inspections outside USA
  • QSR – overview of requirements
  • Detailed requirements and comparison with ISO 13485
  • Workshop
  • Discussion, questions and answers

The course is conducted as lectures and workshops including discussions where each participant is activated.

No of participants


Maximum 16
Qualification test Upon request
Documentation Provided by PREVENTIA AB. The documentation contains copies of slides, regulatory texts and guidelines.


Contact us if you have questions or if you would like us to send an offer!

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