MDIC Accepting Applications for the Accelerate Sustainable Capability (ASC) Pilot Study The Medical Device Innovation Consortium (MDIC) continues to accept applications to participate in their Accelerate Sustainable Capability (ASC) pilot study. This MDIC pilot study is intended to help manufacturers who have difficulty achieving and sustaining regulatory compliance by providing insights to: - Improve product quality and safety
- Reach compliance quickly
- Structure their systems for continuous quality improvement.
Manufacturers who seek assistance in achieving and sustaining compliance are encouraged to apply to MDIC. Interested manufacturers will be considered on a first-come, first-served basis with a preference for manufacturers that meet these test case scenarios, including manufacturers of any size: - That self-identify major deficiencies with the Quality System regulation as defined in the Compliance Program 7382.845
- That have major deficiencies with the Quality System regulation as defined in the Compliance Program 7382.845 observed in inspection but with no advisory action yet issued by the FDA.
- With an open Warning Letter or Untitled Letter, or manufacturers with whom the FDA has requested a Regulatory Meeting as defined in Chapter 4 and 10 of the Regulatory Procedures Manual.
As one of the benefits of participating in the pilot, MDIC will cover the costs of the Capability Maturity Model Integration (CMMI) appraisal and other activities conducted under the pilot. There is no fee to apply. Information on how to apply to MDIC can be found on the ASC pilot study announcement webpage. Questions? If you have questions about this pilot study, contact MDIC Case for Quality Program Director, Alan Baumel (abaumel@mdic.org). | 
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