For over 30 years, Mark Rutkiewicz has managed most medical device company business processes. He has designed Quality Management Systems for active and non-active implantables, disposables, combo devices, software and capital systems. Mark built and rebuilt online integrated corporate-wide quality/business systems. He has a Bachelor of Electrical Engineering from the University of Minnesota and a Masters of Applied Liberal Studies from Hamline University. Since July 2013, Mark has been the VP of Quality at Innovize. He is active in the MDIC Maturity Model Project. Mark is the author of two books on Consiliso, which define how to implement integrated business processes.
CMMI in the Healthcare Industry
Medical Device Discovery Appraisal-The Innovize Experience
The Medical Device Innovation Consortium (MDIC) is driving quality improvements for medical device companies through the Case for Quality (CfQ) project, specifically developing a maturity model assessment for the industry. In July 2017, the FDA introduced the Medical Device Discovery Appraisal Program (MDDAP) and is now offering regulatory incentives to sign-up for the program. Innovize is one of the first companies to go through pilot assessments. The MDDAP program, the FDA incentives and the Innovize experience will be reviewed.
Takeaway: Getting involved with the new program may save you time and money on FDA inspections and 30 day notices.