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Companies With Quality Systems Troubles Can Get On Road To Better Compliance With ASC Pilot

The new FDA/MDIC pilot program is modeled after the popular Case For Quality Voluntary Improvement Program

 
• By Shawn M. Schmitt

Calling all manufacturers with spotty quality systems compliance histories or US FDA warning letters on their desk: The agency wants you for a new pilot program it’s coordinating with the Medical Device Innovation Consortium. The Accelerate Sustainable Capability (ASC) pilot aims to boost manufacturing and process quality, as well as improve compliance at underwhelming firms.

Better days ahead sign

Medical device makers that have spotty quality systems compliance histories or warning letters from the US Food and Drug Administration are being courted for a new agency pilot program to improve the maturity of their manufacturing organizations.

The FDA said on 29 July that it’s working with the Medical Device Innovation Consortium (MDIC) to offer the voluntary...

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