Two Harbors Consulting Podcast

2HC ep 5: Appraisals and Audits

May 08, 2020 Two Harbors Consulting LLC
Two Harbors Consulting Podcast
2HC ep 5: Appraisals and Audits
Chapters
Two Harbors Consulting Podcast
2HC ep 5: Appraisals and Audits
May 08, 2020
Two Harbors Consulting LLC

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.  

Are you enjoying this podcast?  If so, please share it with a colleague!  We'd love to have more people engage with us in these conversations.  And we always want your feedback about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  

Becky Fitzgerald:  becky.fitzgerald@twohc.com
Tom Klein tom.klein@twohc.com
George Zack george.zack@twohc.com

Show Notes

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.  

Are you enjoying this podcast?  If so, please share it with a colleague!  We'd love to have more people engage with us in these conversations.  And we always want your feedback about any element of podcast.  Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com.  

Becky Fitzgerald:  becky.fitzgerald@twohc.com
Tom Klein tom.klein@twohc.com
George Zack george.zack@twohc.com