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CMMI Institute

Capability Counts 2018

Medical Device Discovery Appraisal - The Innovize Experience

3:15 PM - 3:55 PM

The Medical Device Innovation Consortium (MDIC) is driving quality improvements for medical device companies through the Case for Quality (CfQ) project, specifically developing a maturity model assessment for the industry. In July 2017, the FDA introduced the Medical Device Discovery Appraisal Program (MDDAP) and is now offering regulatory incentives to sign-up for the program. Innovize is one of the first companies to go through pilot assessments. The MDDAP program, the FDA incentives and the Innovize experience will be reviewed. Takeaway: Getting involved with the new program may save you time and money on FDA inspections and 30 day notices.