The FDA will be announcing a pilot program in 2018 to give a gift to the industry, click link https://medtech.pharmamedtechbi.com/MT104889/Gifts-For-Industry-From-Waived-Inspections-To-PreMarket-Leeway-US-FDA-Woos-Firms-For-Maturity-Pilot
Innovize was the first company assessed as a proof of concept for this new program through MDIC Case for Quality. http://mdic.org/cfq/
CMMI assessors did a proof of concept review the Innovize Quality System in June 2016 and a second pilot assessment in October 2016. These assessments provided a structured roadmap to improve the capability of Innovize and provide world class business processes.
Innovize’s Quality VP, Mark Rutkiewicz has been a key member of the MDIC’s maturity model team and has provided significant input on the development of the Medical Device Maturity Model.
