FDA Mulls Variant CMMI Maturity Model Program For 'Struggling' Device Companies

Device-makers that are shut out of the US agency's Case for Quality Voluntary Improvement Program (CFQ VIP) because of poor compliance histories may soon be able to join an alternative initiative that would use an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework to assess manufacturing maturity and quality.

Thrown life buoy saving drowning person. - Image

Device-makers with less-than-stellar compliance histories may soon be able to join a variation of a program offered by the US Food and Drug Administration that assesses a company's manufacturing maturity and quality.

The Case for Quality Voluntary Improvement Program (CFQ VIP) – run jointly by the agency and the Medical Device Innovation Consortium (MDIC) – aims to elevate product, manufacturing and process quality at device firms by appraising the companies against an industry-modified version of the

More from Regulation

More from Policy & Regulation