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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

Miss the update regarding the CDRH and CMMI Medical Device Discovery Appraisal Program (#MDDAP) at the recent MDIC Case for Quality forum? Watch it here: https://youtu.be/cs2V4tBSWT4  

The latest article from MedTech Insight regarding the Medical Device Discovery Appraisal Program. This 3rd in a series of articles has feedback from early adopters in industry regarding the program. Contact us at Two Harbors if interested in hearing how FDA is partnering with medical device manufacturers in industry and MDIC to leverage the CMMI framework, provide regulatory modifications, and improve quality of products and services. https://medtech.pharmaintelligence.informa.com/MT122520/Boston-Scientific-Edwards-Lifesciences-Baxter-Used-CMMI-To-Measure-Their-Manufacturing-Capability-He

A nice review of the @CMMI_Institute Capability Counts Conference. Hope to see you there in 2019. https://www.youtube.com/watch?v=RiEjb_4Bz1s

The latest webinar regarding the maturity model program as a part of the Case for Quality is available from MDIC.  https://lnkd.in/efXnq9N It was great that we had two different medical device manufacturer participants presenting on their experience in the program.  Contact us if you have any questions.