FDA proposes a Center of Excellence for Digital Health

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.”

Third in series MDICx webinar and Greenlight Guru series regarding the Case For Quality.

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 […]

#makeCAPAcool

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

3rd in Medtech Insight articles regarding Medical Device Discovery Appraisal Program (MDDAP)

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