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What's In A Name? FDA To Rechristen Its Popular CMMI Maturity Model Appraisal Program This Year

Executive Summary

The joint US FDA/MDIC Voluntary Medical Device Manufacturing and Product Quality Pilot Program – which aims to assess the manufacturing maturity of device firms – will be renamed the "Case for Quality Voluntary Improvement Program," or CFQ VIP. Meanwhile, MDIC says it has launched a new working group to guide development of the burgeoning initiative.

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FDA’s Case For Quality Head Explains The Agency’s 2020 Maturity Model Pilot For Naughty Manufacturers

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.

FDA Awards MDIC $2.8M To Extend Maturity Model Program To Noncompliant Firms, Launch Cybersecurity 'Boot Camp,' And More

The US agency has awarded $2.8m to the Medical Device Innovation Consortium (MDIC) to develop a variant maturity model program for noncompliant device-makers, launch a "boot camp" on cybersecurity threat modeling for devices, and study advanced manufacturing practices used in other industries.

Assessing A Device-Maker's Manufacturing Capability Is Serious Business For These 2 Longtime CMMI Appraisers. Here’s Their Story

From training classes to onsite observations, two lead appraisers affiliated with Pittsburgh's CMMI Institute describe the high hurdles they jumped to be part of a flourishing US FDA pilot program that aims to elevate product, manufacturing and process quality at device firms. The pilot uses an industry-tailored version of the tried-and-true Capability Maturity Model Integration (CMMI) framework that's been around for decades. Beth Layman, an appraiser who has assessed more than a hundred companies in a variety of industries, says appraisers can't just be book-smart – rather, they must also possess a select set of personal skills, including flexibility and open-mindedness. Her fellow appraiser Thayne Hill, who "was there in the early days" of the Capability Maturity Model, says device-makers are often leery of appraisers because of past negative interactions with regulators, which can make his job challenging.

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