FDA to Propose Quality Metrics for Devicemakers by Oct. 1

August 18, 2016

The FDA plans to unveil by Oct. 1 its own quality metrics for devicemakers based on three metrics from a pilot program conducted by Xavier Health and the Medical Device Innovation Consortium.

The three metrics developed under the MDIC/Xavier Health pilot are:

  • The total number of product changes related to product or process failures during pre-production activities compared to the total number of projects;
  • The number of units manufactured without nonconformances (i.e., right first-time rate) during production; and
  • Post-market indicators such as complaints, service records, installation failures, medical device reports and recalls.

Pre-production metrics were identified as the most difficult to track because very few companies track the number of changes due to inadequate product and process development. — Tamra Sami

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