Author: twoharbors
Updates on the Case For Quality
From the tail of last year, but insightful related to the direction for some of the elements of the Case for Quality. https://www.youtube.com/watch?v=pIvLWQbrTcY&feature=youtu.be
Case for Quality Voluntary Improvement Program (also known as the Medical Device Discovery Appraisal Program) white paper
The CMMI Institute has published the FDA written white paper that describes the state of the MDDAP pilot program through September of 2019. Read / download it here: https://cmmiinstitute.com/getattachment/9f083064-60a1-4d2a-be58-3602f60d154f/attachment.aspx
Annual Public Forum recordings are up
MDIC Annual Public Forum session recordings are up. https://lnkd.in/eDnyQV2
MDIC, FDA seeks public comment on MDDAP
Read up on what we have accomplished in this program with the medical device industry, FDA, the CMMI Institute, MDIC and the appraiser community: https://mdic.org/fda-releases-case-for-quality-pilot-program-report-seeks-feedback
Digital Health Precertification Update from RAPS
An update out of RAPS on the state of Digital Health Pre-certification: https://www.medtechdive.com/news/to-pitch-pre-cert-to-congress-fda-builds-a-case-first/563583/
MDDAP looks to develop variation for “struggling sites”
“That’s why the FDA is collaborating with the MDIC and Pittsburgh, PA-based CMMI Institute to develop a variation of the VIP program for struggling sites” — read more in the latest Medtech Insight article about the collaboration between FDA CDRH, the CMMI Institute, MDIC, Medical device manufacturers and appraisers in the Case for Quality Voluntary Improvement Program. https://medtech.pharmaintelligence.informa.com/MT125637/FDA-Mulls-Variant-CMMI-Maturity-Model-Program-For-Struggling-Device-Companies
MDIC APF on CfQ
We missed the MDIC Annual Public Forum this week as we were on a Case For Quality Medical Device Discovery Appraisal – but it was wonderful to see the updates from partners in industry, at the CMMI Institute, the FDA, and MDIC regarding the progress of this innovative and collaborative program that is changing the landscape from a culture of compliance to one of Quality and compliance. Proud to be a part of this effort! […]
Latest MDICx webinar
Latest @MDIConline webinar on the @caseforquality Medical Device Discovery Appraisal Program @mddap webinar. Great feedback on use of the @CMMI_Institute framework for a multisite appraisal in this @FDADeviceInfo program. Let us know of any questions: https://www.youtube.com/watch?v=BSc_chEWuMw
The “origin story” of the Case For Quality Medical Device Discovery Appraisal Program
Catch the “origin story” of the Case For Quality Medical Device Discovery Appraisal Program in this Greenlight Guru “True Quality Stories” podcast interview with Becky Fitzgerald. https://www.greenlight.guru/blog/becky-fitzgerald-two-harbors-consulting. Let us know if you have any questions or interest in this collaborative program between FDA, Industry, MDIC and the CMMI Institute.
