The Medical Device Innovation Consortium, MDIC, on August 1, 2016, published Medical Device Quality Metrics – Best Practices Document for Metrics Identified Across the Total Product Lifecycle. The document supports the FDA CDRH Office of Compliance Case for Quality initiative.
It recommends metrics in three broad areas: Pre-production, Production, and Post-production. In each area, it names the metrics and provides a formula for calculating its value. In addition, Appendix B provides an example of the complaint metric analysis with a risk profile.
The report is available from the MDIC resource center http://mdic.org/cfq/resource-center-for-sustained-quality