There is a public view of the capability areas, practice areas and practices as defined in 2.0 version of the CMMI model as of 04DEC2019. You can get that here. https://cmmiinstitute.com/resource-files/public/v2-0-materials/cmmi-v2-0-quick-reference-guide
Great to hear the perspective from Francisco Vicenty at FDA CDRH on how the Medical Device Discovery Appraisal Program (#MDDAP) is progressing. https://www.greenlight.guru/webinar/fda-case-for-quality-3-success?submissionGuid=06c12318-ecde-48bd-aa32-5a9dc31d67f6
Below are two links to two articles regarding the Medical Device Discovery Appraisal Program (MDDAP) from the on-line publication, MedTech Insight. These articles are part of a series that MTI has been doing on the program. These articles specifically get into appraiser qualifications and their insights on this program and the possibility of FDA staff being a part of appraisal teams. https://medtech.pharmaintelligence.informa.com/MT122521/Assessing-A-DeviceMakers-Manufacturing-Capability-Is-Serious-Business-Longtime-CMMI-Appraisers-Give https://medtech.pharmaintelligence.informa.com/MT123294/FDA-Staffers-Device-Firm-Employees-Are-Training-As-Appraisal-Team-Members-For-CMMI-Maturity-Model-Pi
Latest podcast from MedTech Insight regarding #MDDAP and lead CMMI appraiser credentials. https://overcast.fm/+DjJgAU44Y
From https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620246.htm “This Center of Excellence would help establish more efficient regulatory paradigms, consider building new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices. Our Digital Health Innovation Action Plan demonstrates our commitment to spurring digital health innovation and safety. With the creation of a Center of Excellence, the FDA could commit additional resources to helping developers create innovative products that can benefit patients.”
Last week was a third MDICx webinar regarding the MDDA program. In addition to Kim Kaplan from the CMMI Institute and Cisco Vicenty from FDA CDRH providing updates regarding the program, Kathy Bardwell from Steris and Stephanie Fossat-Dominguez from Celonova presented on their experiences in the program. You can rewatch the webinar here: https://www.youtube.com/watch?v=wvwC97SGH-M Additionally, Greenlight Guru will host a third in a series of webinars with Cisco Vicenty regarding efforts in the Case for […]
Part 3 in the @Medtech_Insight podcast series on the CDRH Medical Device Discovery Appraisal Program (#MDDAP) that leverages the CMMI Framework. https://medtech.pharmaintelligence.informa.com/articles/2018/07/13/device-week-july-13-2018–medtechs-next-top-maturity-model-part-3
Greenlight Guru webinar with FDA CDRH Case for Quality Manager Francisco Vicenty regarding where the CfQ is at and where it is going. https://www.greenlight.guru/webinar/fda-case-for-quality-success?submissionGuid=ea5a241f-565c-4e9b-812d-aeefbcc87b61
Great read from Fortune magazine on the shift at FDA regarding mobile and digital health.http://fortune.com/2018/07/09/fda-mobile-health-digital-health
Future initiatives were discussed at the recent MDIC Case for Quality forum – and it included conversations on revisiting CAPA to #makecapacool https://medtech.pharmaintelligence.informa.com/MT122903/With-New-Initiatives-Case-For-Quality-Embarks-On-Mission-To-Create-Safe-Space-Engage-CEOs-makeCAPAco
