Feb 1, 2024 | Issue of the Month, Medical Devices
The Importance of the Medical Device Single Audit Program (MDSAP) and EU MDR Lead Auditor Certifications By Kevin Walls, MBA, EAS Independent Consultant The Medical Device Single Audit Program (MDSAP) is a certification program many medical device manufacturers are...
Aug 1, 2015 | Issue of the Month, Medical Devices
By EAS Senior Consultant Kevin Walls The Food and Drug Administration has recently implemented two new rules that affect all medical device manufacturers, initial distributors and repackager/relabelers. The first new rule that went into effect on September 24, 2014,...