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Quality Control & Compliance

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Q3 Recalls Snapshot: Recalled Devices Slide In Third Quarter; Software A Nagging Issue

Good news for the medical device industry: After two record-setting quarters, the number of recalled products and device units fell in the third quarter of 2018. Yet device-makers are still having problems with software, which was the leading cause of recalls in Q3. Check out our Q3 recalls infographic.

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Fresh From US FDA's Chief Counsel Office, Beth Weinman Talks Qui Tam And Compliance

Beth Weinman, a former enforcement lawyer in US FDA’s Office of Chief Counsel, recently joined the life sciences and FDA regulatory practice at Ropes & Gray. She spoke with Medtech Insight about whistleblower suits and FDA enforcement priorities.

Compliance Enforcement

US FDA Tweaks Direct Marking Rules In UDI Enforcement Delay

FDA’s latest update to Unique Device Identification compliance deadlines says the agency won’t enforce direct marking UDI rules for some existing devices if the UDI can be determined in other ways.

Enforcement Compliance

'An Unnecessary Editorial Revision': In Letter, MDSAP Council Rails Against ISO's Push To Change 13485 Quality Standard

The chair of the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council is warning of "instability" in industry if the International Organization for Standardization (ISO) Technical Management Board has its way and makes changes now to international quality systems standard ISO 13485.

International Standards

ISO Wants To Tinker With Quality Systems Standard 13485:2016. Let ISO Know What You Think By Nov. 9

Device firms don't have to conform to the latest version of ISO 13485 until March 2019, yet the International Organization for Standardization (ISO) Technical Management Board is champing at the bit to open up the quality systems standard for a rewrite. In response, ISO Technical Committee 210 has developed a survey to determine how changing the standard will affect device-makers and other stakeholders. TC210 wants to "gather opinions from the users [of ISO 13485] to justify why no immediate revision is desired, especially in light of all the regulatory changes that are coming," TC210 delegate Kim Trautman says. The survey closes Nov. 9.

International Standards

Compliance Corner: 8 Handy Tips From An MDSAP Auditor To Help You Ace Your Next Audit

NSF International's Brian Ludovico offers up advice for device-makers facing an audit under the Medical Device Single Audit Program.

Compliance Corner International

Investigator Horror Stories 3: Boozing On The Job? Yup, That Happened – As Have These Other Shocking Tales Of Irregular FDA Inspections

In the final chapter of our Investigator Horror Stories trilogy, former US FDA investigations branch director Ricki Chase tells how one agency investigator blatantly drank alcohol and asked for bathing suit suggestions during an audit in Greece, and longtime industry insiders Steve Niedelman and David Chesney offer up three bone-chilling stories of investigators who stepped over the line. Check out how they handled the outlandish inspections in this Compliance Corner threequel.

Compliance Corner FDA

FDA Hasn't Publicly Released A Device-Related Close-Out Letter For 5 Months, Defeating Purpose Of Program

Medical device manufacturers under the dark cloud of a US FDA warning letter work hard to close them out, and, importantly, receive a close-out letter from the agency that is posted online for everyone to see. Yet FDA hasn't publicly released such a missive to device companies since May – the longest gap since the close-out program began in 2010. FDA says it's aware of the problem.

FDA Compliance

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

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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