George, Becky and Tom of Two Harbors Consulting discuss the differences, similarities and value add of appraisals and audits. Is one better than the other? Can you get a map between the medical device quality system regulation (QSR) and the CMMI? Why aren't their maturity levels used in the Case for Quality appraisal program?
A few concepts referred to in the episode:
CMMI: https://cmmiinstitute.com/
The Medical Device Discovery Appraisal Program or MDDAP (also referred to as the Case For Quality Voluntary Improvement Program): https://cmmiinstitute.com/medicaldevice
Medical Device Innovation Consortium (MDIC) Case For Quality: https://mdic.org/program/case-for-quality/
Quality System Regulation (820): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
Also - check out 2HC at the upcoming Greenlight Guru Virtual Quality Summit: https://virtual-summit.greenlight.guru/?sc=QVIW4uUc&ac=qbB2QCbS Two Harbors Consulting is proud to partner with the great team at Greenlight on this amazing conference coming up in June.
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Becky Fitzgerald: becky.fitzgerald@twohc.com
Tom Klein tom.klein@twohc.com
George Zack george.zack@twohc.com