“As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion … ” https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609188.htm
This is the second podcast from Medtech Insight covering the Medical Device Discovery Appraisal Program (#MDDAP). The program leverages the CMMI framework so device manufacturers get feedback regarding their capabilities. In turn they also receive regulatory benefits from CDRH. Give it a listen and let me know what you think. https://soundcloud.com/pharmaintelligence/device-week-may-24-2018-medtechs-next-top-maturity-model-part-2
Part 2 of the Medtech Insight articles on the Medical Device Discovery Appraisal Program. https://bit.ly/2K6TWRV In this article, Baxter speaks to their rationale for getting involved in the program, and how using the CMMI framework for process improvement is important to them.
Part 1 of the Medtech Insight series on the Medical Device Discovery Appraisal Program (#MDDAP) by Shawn Schmitt. Provides a good oversight on the basics of the program that has CDRH using the CMMI framework to asses and organization’s capabilities with the provision of regulatory benefits to medical device manufacturers. https://bit.ly/2jGPlL1. Contact us at Two … More Chasing Quality Isn’t Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites
Overview in podcast form of FDA’s Medical Device Discovery Appraisal Program (#MDDAP) by Shawn Schmitt (@MedtechShawn). Contact us at Two Harbors if you are interested in leveraging the CMMI framework to assess your med device organization capabilities. https://lnkd.in/gNQbZvM