Thinking about using CMMI? Here are tips from the experts

Considering the voluntary U.S. FDA pilot program that uses Capability Maturity Model Integration (CMMI) Before you sign up, read this article. You’ll learn what quality, compliance and regulatory officials at the three large device firms (including Baxter) have to say about the value of the program. They explain the benefits of participation and share their approaches. The article also walks readers through of the CMMI appraisal process. (Hint:It’s nothing like a typical regulatory audit.) Finally, it also explores how Baxter created its own maturity model. This is the third in a Medtech Insight series on the appraisal of manufacturing capability and maturity.