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