MDSAP Auditors Aren't Applying A Consistent Auditing Approach, Medtech Group DITTA Claims In Letter To FDA
Executive Summary
A letter from DITTA Chair Patrick Hope to a US FDA point person for MDSAP highlights concerns some device-makers have about the flourishing Medical Device Single Audit Program, including inconsistent auditing approaches from facility to facility, and long-delayed audit results and MDSAP certificates.