Two Harbors Consulting has been working closely with partners in industry, the Medical Device Innovation Consortium, the Food & Drug Agency, and the CMMI Institute to further the Case for Quality program leveraging the CMMI Maturity Model as a framework to assess and drive quality improvements in medical device firms.
As background, please review FDA Director of CDRH, Dr. Jeff Shuren describes the Case for Quality here.
The CMMI Institute has provided a comprehensive FAQ regarding this program on their website here.
The FDA announced this pilot program in the Federal Register on July 25, 2017.
Recently (October 10, 2017), Two Harbors Consulting, LLC team member George Zack presented at the Agency with CMMI Program Manager Kim Kaplan on the details of this program. You can review a video of their presentation here. Additionally, at the recent MDIC CfQ forum (November 15, 2017) Kim and George provided an update on the status of this pilot program.
If you are interested in or have questions regarding this program as a medical device firm, a CMMI lead appraiser or appraisal team member, or otherwise as an interested stakeholder in the industry, please contact us as Two Harbors Consulting.
