Notified Bodies Received New Guidance from MDCG on the Use of MDSAP Audit Reports for MDR and IVDR
Author: Dr. Suzanne Broussard | September 28, 2020 Medical device manufacturers received clarification on how the European Commission’s Medical Device Coordination Group (MDCG) will allow Notified Bodies (NBs) to use Medical Device Single Audit Program […]
The Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) Mandate that Device Manufacturers Have a Person Responsible for Regulatory Compliance (PRRC): Guidelines and Support
Author: Suzanne Broussard | September 07, 2020 The newly created Person Responsible for Regulatory Compliance (PRRC) position is a unique regulatory requirement that applies only to the European Union, and is a key area of responsibility for a person […]
