The CDRH pilot program leverages a proven maturity model, the CMMI framework, by which medical device organizations may measure their capability to produce high quality devices and increase patient safety. This measurement can then be used by the organization to drive targeted continuous improvement activities throughout their facility.
In recognition of manufacturers who complete this independent assessment of quality maturity, FDA will adjust that manufacturer’s engagement activities and change submission requirements.
Initial enrollment into the pilot program is now open.
Enrolling your organization at this time provides the following:
- Initiates recognition of regulatory benefits from the FDA
- Moves the maturity model program forward for industry, FDA, MDIC and the CMMI Institute as a part of the overall Case for Quality
- Drives the maturity model program forward to begin initial execution of PMO operational activities
- Initiates the process of the FDA determining your qualifications for the program, as well as initiates scoping, and scheduling conversations
We encourage you to enroll now as initial early adopter slots will be limited. Contact CMMI if you have questions at firstname.lastname@example.org.
Additional information can also be found in the Federal Register notice.