FDA’s Case For Quality Head Explains The Agency’s 2020 Maturity Model Pilot For Naughty Manufacturers
• By Shawn M. Schmitt
Cisco Vicenty tells how the US agency will structure its pilot program for device-makers with less-than-stellar compliance histories that want to use the CMMI maturity model framework to improve the quality and maturity of their manufacturing organizations – and clean up their compliance problems along the way. The FDA – which is partnering with the Medical Device Innovation Consortium (MDIC) and Pittsburgh’s CMMI Institute on the voluntary pilot – will offer the opportunity to 10 firms “that have had a negative inspection outcome, a warning letter, or possibly other regulatory action,” Vicenty explains to Medtech Insight. The pilot launches next year.
Ten noncompliant firms will be selected for the NCS VIP pilot
The US Food and Drug Administration will be looking soon for 10 manufacturers with problematic compliance histories to volunteer to play in a pilot program to improve the quality and maturity of their manufacturing organizations – and clean up their compliance issues along the way.
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