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MDIC’s ASC Pilot Shows Continuous Improvement Approach May Work For More Manufacturers

 
• By Elizabeth Orr

A recent pilot program from public-private partnership MDIC attempted to apply the FDA’s established Voluntary Improvement Program framework to manufacturers with known compliance issues. Participants found an improved mindset, a better relationship with the FDA, and conclusions to ongoing enforcement actions.

Wooden blocks with continuous improvement graphic.
(3rdtimeluckystudio/Shutterstock)

Manufacturers with documented compliance problems may benefit from interventions modeled on the US Food and Drug Administration’s Voluntary Improvement Program (VIP), a recent report from the Medical Device Innovation Consortium (MDIC) states.

VIP helps manufacturers improve their overall operations through the use of industry best practices, standardized benchmarks, and third-party assessment under the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system. The approach appears to be successful:

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