Archive for May, 2017

Innovize Leads the Industry in Developing Quality System Assessments

 

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.

 

 

 

 

Innovize