Chasing Quality Isn’t Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites

Part 1 of the Medtech Insight series on the Medical Device Discovery Appraisal Program (#MDDAP) by Shawn Schmitt.

Provides a good oversight on the basics of the program that has CDRH using the CMMI framework to asses and organization’s capabilities with the provision of regulatory benefits to medical device manufacturers. https://bit.ly/2jGPlL1.  Contact us at Two Harbors if interested or if you have any questions.