April 18–19, 2018Boston Convention & Exhibition CenterBoston, MA

BIOMEDevice Boston 2018 Schedule Viewer

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Case Study: Case for Quality: Implementing the Medical Device Company Maturity Model


Mark Rutkiewicz (Vice President, Quality, Innovize)

Location: 160 B

Date: Thursday, April 19

Time: 2:00pm - 2:30pm

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: Biomed Track B: Product Development

Vault Recording: TBD

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, 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.

Topics covered will include:
  • How the program focuses on project management best practices to accelerate time to market
  • Exploring how the program looks at efficient implementation of design controls
  • Ways the new program can save you time and money on FDA approvals
  • A review of the MDDAP program, FDA incentives, and the Innovize experience