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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.

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