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.
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...