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Quality On The Brain: FDA Maturity Pilot Aims To Shift Industry's Compliance Mentality To A 'Quality Mindset'

 
• By Shawn M. Schmitt

An upcoming voluntary pilot program from US FDA will be the perfect vehicle to help drive a compliance-to-quality culture change at medical device firms, developers of the program say. To be stood up early next year, the pilot will see manufacturers use third-party assessors to measure the maturity of their quality systems and manufacturing processes. In a survey, early users of the Capability Maturity Model Integration (CMMI) appraisal process said it helped them identify ways to increase product quality.

Light bulb in hand with brain

Becky Fitzgerald has quality on her mind, and she wishes that more medical device manufacturers did, too.

In the industry, "there's a bit of a gap, if you will, between the compliance perspective" – device-makers wanting to make sure they meet US FDA regulations – "and the quality mindset," Fitzgerald said

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