Mark Rutkiewicz, Innovize Quality VP and Founder of Consiliso will be speaking the at the MDM Minneapolis show at 9:15 am on Wednesday October 23rd on the FDA Case for Quality: How to Structure Your CMMI Assessments for Competitive Advantage & Improved Result. 

In July 2017, the FDA introduced the Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which is now called the Case for Quality Voluntary Improvement Program (CfQ VIP). The FDA program offers regulatory incentives for member companies; participants typically see increased innovation through faster submission reviews, improved employee morale, and decreased time to market for device improvements.

Innovize completed three CMMI assessments and will undergo their fourth this month.  The CMMI assessment can cover up to 26 practice areas; however, you only need to have 10-13 areas assessed.  As part of the program, Mark will explain how you should tailor the assessment to your company’s needs.  Mark will briefly review the Innovize experience in the program, and discuss how other companies have also used the program with excellent results.

This session will provide details on each practice area, how to select your assessment level, and who in your company should attend the assessment sessions.

Innovize and it’s sister company, Consiliso, have made a significant commitment to the CfQ VIP and will continue to work closely with the FDA on its improvement. As the first medical device manufacturer to undergo a CMMI assessment under the pilot program, Innovize and Consiliso remain leading partners between regulators and industry as we continuously improve not only our own company, but the compliance and quality culture of the medical device industry.

For more information on the CfQ VIP, see the FDA Case for Quality Pilot Program page at www.fda.gov/medical-devices/quality-and-compliance-medical-devices/case-quality-pilot-activities

For information on how Consiliso helps medical device companies create efficient, compliant business processes that support instead of hinder continuous improvement, see www.consiliso.com.

To learn more about Innovize and its world-class capabilities as a medical device converter, visit www.innovize.com.