Cost Savings for MDDAP appraisals over typical compliance audits by FDA

“Edwards Lifesciences is among the companies participating in the pilot program, and Rob Becker, director of quality at Edwards, said the MDDA audit that the company went through in 2017 ended up costing Edwards about $74,000 compared to a traditional compliance audit that would have cost closer to $140,000. What’s more, Becker said the process … More Cost Savings for MDDAP appraisals over typical compliance audits by FDA

Presentations from FDA Digital Health Precertification 30JAN2018 Workshop

Presentations from #FDAPreCert 30JAN2018 workshop are up. @CMMI_Institute presentation starts on p. 29. https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM597304.pdf Contact @2HarborsConsult about #MDDAP if interested in pilot program providing regulatory benefits now @KimKaplan_US @bltfitz @MDIConline

FDA wants to create a Center of Excellence on Digital Health

FDA Commissioner Scott Gottlieb (@SGottliebFDA) wants to create a Center of Excellence on Digital Health “to establish the regulatory paradigm, build new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices. To modernize and expand its existing capabilities to ensure the cybersecurity of medical devices, … More FDA wants to create a Center of Excellence on Digital Health

MDICx – Quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program February 27, 2018 – 12 p.m. eastern

Interested in the Medical Device Discovery Appraisal Program (#mddap) and how it uses @CMMI_Institute framework to help medical device companies and get regulatory modifications from the @FDAcdrhIndustry? Attend the next CfQ webinar Feb 27: http://mdic.org/mdicx/ In 2017, CDRH launched a pilot project designed to incentivize medical device manufacturers to demonstrate mature quality practices by reducing … More MDICx – Quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program February 27, 2018 – 12 p.m. eastern

Interview with Cisco Vicenty regarding the Case for Quality

Just over an hour long, Dan Matlis sat down with the Program Manager for the Case for Quality, Cisco Vicenty to discuss the goals and state of the program.  https://www.youtube.com/watch?v=Z4BLB3yZuGw.  Cisco discusses the objectives of the CfQ, what FDA have been learning from the program and the CMMI Medical Device Discovery Appraisal Program (MDDAP).