The latest MDIC June 20 Case for Quality Forum – Slides and recordings from the event are now available: https://mdic.org/event/june-20-2019-case-for-quality-forum/. Specifically the video recording of the update on this program is at: https://www.youtube.com/watch?v=EO2WYAzB4Oc. Francisco Vicenty from CDRH also does an update specifically from the CDRH perspective at: https://www.youtube.com/watch?v=EuTtQsNaNCQ
Check out the interview that CMMI Lead Appraiser Henry Schneider does with FDA OPEQ Case for Quality Manager and thought leader Francisco Vicenty on the Medical Device Discovery Program. https://www.youtube.com/watch?v=dAC_kKmDoGY
Slides and recording from the most recent MDICx webinar are up: https://mdic.org/event/update-on-the-case-for-quality-voluntary-improvement-program-cfq-vip/ Let us know if you are interested or have questions on the program or how you and your organization can be involved. @CMMI_Institute @MDIConline @MddaProgram @FDAcdrhIndustry
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Good read from Stephanie Christopher from MDIC – what are the benefits of proactively investing in quality? https://www.greenlight.guru/blog/proactive-quality-systems
George says, “I have long enjoyed the Global Medical Device podcast series by Greenlight Guru and its host Jon Speer. I was honored to be a guest on it this past week to discuss the Medical Device Discovery Appraisal Program (#MDDAP) and how MDIC, CDRH at the FDA, the CMMI Institute and participating medical device manufacturers are a part of this Case for Quality initiative. Give it a listen, let me know your feedback and contact […]
On January 7, CDRH released its latest update regarding their direction for the Digital Health Precertification program. https://www.raps.org/news-and-articles/news-articles/2019/1/fda-to-test-precert-de-novo-requests-under-pilot The update is significant in that it provides several shifts not previously documented – including leveraging the De Novo approach for SaMD products in the pilot. Additional comments regarding interpretation on this announcement is at: https://www.linkedin.com/feed/update/urn:li:activity:6488161308070985728
Looking forward to digging into reading the @greenlightguru overview on the Case for Quality: https://www.greenlight.guru/blog/fda-case-for-quality-2018-comprehensive-review
https://www.youtube.com/watch?v=9u7WSidbSRU The Q4 webinar on the Case for Quality Medical Device Discovery Appraisal Program #MDDAP is posted. In addition to giving an program status update, this one covers how Edwards Life Sciences leveraged their CMMI discovery appraisal as part of their improvement efforts and what regulatory benefits they have received. Contact any of us at Two Harbors with any questions.
Overview of the MDDAP: https://cmmiinstitute.com/resource-files/public/medical-device-discovery-appraisal-program-program
