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Quality Control & Compliance

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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.

The fourth of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.

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QUOTED. Sept. 25, 2018. Cisco Vicenty.

US FDA's Voluntary Medical Device Manufacturing and Product Quality Pilot Program has become so popular that both the agency and device-makers are sending their own employees to CMMI Institute to be trained as Appraisal Team Members to assist in appraisals at device firms. See what FDA's Cisco Vicenty said about it here.

Quoted FDA

Device Week, Sept. 21, 2018 – Medtech’s Next Top Maturity Model, Part 4

Medtech Insight’s Shawn M. Schmitt talks about Part 4 of “Medtech’s Next Top Maturity Model,” his feature series on the appraisal of device-makers’ manufacturing capability and maturity. This episode focuses on appraisers affiliated with Pittsburgh's CMMI Institute and describes the hurdles they must clear to be part of a US FDA pilot program that uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework.

Device Week Quality Control

FDA Staffers, Device Firm Employees Are Training As Appraisal Team Members For CMMI Maturity Model Pilot

US FDA's ongoing Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which assesses device-makers' manufacturing maturity and capability, has become so popular that both the agency and manufacturers are sending their own employees to CMMI Institute to be trained as Appraisal Team Members, or ATMs, to assist in device-related Capability Maturity Model Integration (CMMI) appraisals.

Quality Control FDA

Medtronic Slapped With 2 FDA Warning Letters For Problems At Minnesota, Puerto Rico Sites

Two Medtronic facilities that make cardiac rhythm management devices were sent warning letters by US FDA because of quality systems issues. The sites were inspected by the agency after the firm initiated high-risk class I recalls for an array of CRM products earlier this year.

FDA Enforcement

Zimmer Warning Letter Confirms Ongoing Issues With CAPA, Process Validation

US FDA has released a six-violation warning letter sent to a Zimmer Biomet facility in Warsaw, Ind. The company had already acknowledged that the letter was a possibility.

Compliance Enforcement

TrialScope Anticipates FDA Will Begin Inspecting Companies For Trial-Reporting Compliance

US FDA will soon ramp-up enforcement of the clinical trial transparency provisions of Title VIII of the Food and Drug Administration Amendments Act of 2007, according to TrialScope Chief Strategy Officer Thomas Wicks. Those that fall foul of these new requirements will face penalties  and it looks like SMEs will be hardest hit.

Clinical Trials Regulation

Device Week, Aug. 22, 2018 – Quality System Regulation + ISO 13485 = ?

On this week’s podcast, Medtech Insight’s Shawn M. Schmitt talks about his recent reporting on US FDA’s plans to merge its bedrock rule for manufacturing safe and effective devices in the United States with international quality systems standard ISO 13485.

Device Week Regulation

The QSR/ISO 13485 Maze: How FDA's Satellite Device Rules Will Complicate A Quality System Regulation Rewrite

Kim Trautman, who authored the Quality System Regulation in the 1990s, says US FDA officials tasked with retooling the QSR will have to consider an array of other device-related rules that address complaints, product recalls and traceability – just to name a few – to make sure those requirements will still be met by manufacturers.

Regulation Standards

Makers Of An Array Of Devices Can Now Report Malfunctions In Summaries To FDA. Did Your Product Make The Cut?

US FDA rolled out its Voluntary Malfunction Summary Reporting Program on Aug. 17, allowing device-makers and manufacturers of device-led combination products to send quarterly rollup adverse event reports to the agency. The program's overarching goal is for FDA to receive fewer individual Medical Device Reports and to lessen the time firms spend preparing them, while maintaining sufficient detail for the agency to effectively monitor devices.

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