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Quality Control & Compliance

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Quality Replay: FDA Urges Firms To Close Loop On CAPAs, Create Filters To Weed Out Poor Quality Data

From our digital archives: Applying a closed-loop approach to corrective and preventive action activities is one of the best ways to ensure device quality and gather useful data, US FDA says. Manufacturers often fail to ensure that they complete the CAPA loop, leading to corrective and preventive actions that might be open for years, or product fixes that don’t work and complicate matters further by presenting the firms with a whole new set of challenges.

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Quality Replay: Device History Record ‘Oversights’ A Clear Path To Quality Troubles, FDA Says

From our digital archives: Manufacturers are overlooking various key elements that should be included in device history records, including up-to-date labels, dates of product manufacture and missing signatures on documents, US FDA says. Because DHRs touch virtually every part of a firm’s quality system, a flawed DHR can prompt agency investigators to dig deeper during inspections. Experts from device firms Baxter and Thoratec weigh in.

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Q2 Recalls Snapshot: Dramatic Increase In Class I Actions; Overall Recalls Dip Slightly

The number of high-risk class I recalls ballooned 88% in the second quarter of 2017. Overall, recalls fell 3%. Check out our Q2 recalls infographic.

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'A Sea Change': Device Center Compliance Chief Touts US FDA's Benefit-Risk Concepts – But Will Manufacturers Buy In?

FDA compliance head Robin Newman is asking manufacturers to share information on troublesome devices to help the agency make benefit-risk decisions that weigh product availability and regulatory compliance. But an industry survey finds that only 17% of firms are willing to hand over such potentially sensitive information. Nevertheless, the agency believes it's vitally important for device-makers to be more forthcoming with data that supports well-informed benefit-risk conclusions, made in the best interest of patients and manufacturers. Driving the data-sharing discussion is a December guidance from FDA that outlines a broad framework for considering benefit-risk factors – a document that Newman says is "a sea change" for how industry and the agency can work hand-in-hand on benefit-risk analyses.

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Compliance Corner: There Are 7 Reasons Why You're Screwing Up Management Reviews, Abbott Quality VP Says

Monica Wilkins, divisional VP of medical, quality and strategic support for device-maker Abbott Laboratories, lays out seven distinct issues that can keep manufacturers from getting the most out of management review meetings.

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US FDA Maturity Model Pilot Program Gets October Meeting Date

The agency wants to hear public feedback on its plan to employ a standardized model to measure a company's manufacturing "maturity" via third-party assessments to support regulatory and compliance decisions.

Quality Control Compliance

Compliance Corner: 6 Tips From US FDA To Ensure Robust Software Validation

Device manufacturers can avoid headaches during agency inspections by following this advice from two FDA investigators.

Quality Control Compliance

Aerospace Heat Treating Standard Recognized By US FDA, Giving Nudge To MedAccred Supplier-Control Program

The agency's Center for Devices and Radiological Health has formally recognized pyrometry standard AMS 2750 for heat treating. Originally drafted by SAE International in 1980 for the aerospace industry, the standard is the foundation of heat treating audit criteria for the burgeoning medical device supply-chain oversight program MedAccred.

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A Stronger Supply Chain: Stryker Tying Process Vendors To MedAccred; Others May Follow Suit As FDA Takes Notice

Suppliers of eight special manufacturing processes – including sterilization, welding and heat treating – will have to be accredited to industry-managed supply-chain oversight program MedAccred if they want to do future business with device giant Stryker. "Awarding business based on accreditation [to MedAccred] is the end goal," the company's manager of supplier controls told Medtech Insight. The program's aim is to ensure high-quality finished devices and offer clearer supply-chain visibility, giving manufacturers greater confidence in the vendors they choose. Industry heavy-hitters Medtronic, Johnson & Johnson, GE Healthcare, Philips Healthcare and Becton Dickinson are also strong supporters and users of MedAccred, giving it even more industry street cred. Meanwhile, resource-strapped US FDA is mulling over how it can best benefit from the burgeoning program.

Quality Control Compliance

Zimmer: Surprised By Biomet Quality Problems, But Responded Before FDA Arrived

Zimmer Biomet's response to a US FDA Form-483 says the firm was unaware of the quality systems woes at the targeted Biomet Warsaw, Ind., plant before its 2015 acquisition of the company. But, it emphasized, comprehensive fixes were in the works even before the 2016 agency inspection that generated more than a dozen substantive observations took place.

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