Innovize and CMMI Partnership with the FDA
In 2015, Innovize’s VP of Quality (Mark Rutkiewicz) joined the small team to implement the maturity model assessment concept. The CfQ project had chosen the CMMI Institute’s model which is called the Capability Maturity Model Integration (CMMI).
With Mark’s 30 years of experience building and rebuilding Quality Systems in all size medical device companies, Mark took on the leadership of the Maturity Model implementation sub team. The first challenge was to get the FDA to agree the CMMI assessment would work, so Mark volunteered Innovize to be the Proof of Concept. Innovize had just passed an FDA QSIT inspection in January of 2016 with no findings. This is a pre-requisite for the CMMI assessment. In June of 2015, this two-day assessment was done at Innovize with the FDA watching the entire interaction over a video feed. The FDA was pleased with the process and it was agreed that a larger pilot was needed.