What is a Lead Appraiser?

Two Harbors Consulting colleague Becky Fitzgerald answers the question what a CMMI Lead Appraiser is and what value they offer. https://www.youtube.com/watch?v=B543NvLv8bA

FDA issues draft guidance for VIP

Long awaited draft guidance for the Voluntary Improvement Program: https://www.fda.gov/media/158180/download  Let us know what you think (in addition to submitting your comments to the docket). Kudos to all (you know who you are) that made this happen over the last handful of years. Thank you for your time, effort, and continuous improvement thinking.

New case study for MDDAP

A new case study posted by CMMI regarding the Medical Device Discovery Appraisal Program (@MDDAP) and the success Edwards Lifesciences has seen in the program. Let us know if you have any questions or want to discuss this innovative program. https://www.isaca.org/enterprise/medical-device-discovery-appraisal-program