While not yet published, the European Commission proposed a new regulation to rebuild the existing European legal framework and resolve weaknesses in the Medical Device Directives. In this whitepaper, we discuss the regulation's new audit and assessment duties for Notified Bodies, including performing unannounced audits. You will learn:
- Manufacturer's need to correctly qualify their devices
- What may be included in the Conformity Assessment
- Quality System Assessment
- How often to expect Unannounced Audits
About the Author:
Alexandre Pétiard is a Senior Quality and Regulatory Consultant with Emergo. He lives in Dijon, France.