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 […]
9 Tips To Ace The MDSAP The First Time
Author: Suzanne Broussard Take the advice of industry experts and AOs—the key to acing the MDSAP audit is to prepare, prepare, prepare. The MDSAP audit process is intense in that […]
What To Expect During An MDSAP Audit
Author: Suzanne Broussard Risk Assessment is the Cornerstone of the MDSAP Audit When preparing for the MDSAP audit, it is important to understand that the audit focuses heavily on risk-based […]
