Quality Control & Compliance
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A recent study by Sparta Systems revealed that more than four in 10 companies, including device-makers, still primarily handle customer complaints on paper, or via a decentralized system like Microsoft Excel or Access. Two quality assurance experts weigh in.
Latest From Quality Control
The US agency is looking for ways to open its upcoming Voluntary Medical Device Manufacturing and Product Quality Program – designed to gauge the manufacturing maturity of device-makers – to smaller firms, officials said at a recent industry meeting. Medtronic and Edwards Lifesciences, in particular, noted that using the Capability Maturity Model Integration (CMMI) appraisal framework could allow them to save hundreds of thousands of dollars in FDA submissions and 30-day notice fees, among other expenses.
'Super Office' To The Rescue: FDA's Device Center Is About To Undergo A 'Total Product Life Cycle' Makeover
CDRH Director Jeff Shuren told industry that the device center is moving quickly to establish a "super office" to tackle the full spectrum of pre- and post-market issues to reduce inefficiencies to replace the more siloed approach. Chief Scientist Bill Maisel has already been named a director.
Quality On The Brain: FDA Maturity Pilot Aims To Shift Industry's Compliance Mentality To A 'Quality Mindset'
An upcoming voluntary pilot program from US FDA will be the perfect vehicle to help drive a compliance-to-quality culture change at medical device firms, developers of the program say. To be stood up early next year, the pilot will see manufacturers use third-party assessors to measure the maturity of their quality systems and manufacturing processes. In a survey, early users of the Capability Maturity Model Integration (CMMI) appraisal process said it helped them identify ways to increase product quality.
The survey of more than a thousand consumers shows that manufacturers might want to change the way they interact with people between the ages of 18 and 34 when communicating information about device recalls.
Monica Wilkins, divisional VP of medical, quality and strategic support for device-maker Abbott Laboratories, returns to Compliance Corner with more tips for management reviews. This time, she pinpoints five things that manufacturers should discuss during the meetings.
Device-Makers Can Forego US FDA Pre-Approval Inspections By Joining New 'Critical-To-Quality' PMA Pilot
Nine manufacturers will be selected to play in the agency's voluntary "Premarket Approval Application Critical to Quality" (PMA CtQ) pilot program. Participants will "discuss device design and manufacturing process quality information with FDA early on" to assist "in its review of the PMA manufacturing section and post-approval inspections," the agency says in a notice set to publish in the Sept. 12 Federal Register.
The FDA Reauthorization Act, enacted last month, includes provisions that aim to improve FDA's inspection process, including putting a stop to arbitrary audit scheduling by the agency – a practice that can cause a facility inspection to drag on for weeks at a time. FDA has until early 2019 to draft a guidance document that lays out how it will ensure a more uniform inspection process that ensures greater parity between foreign and domestic audits. Steps mandated by the new law include notifying firms in advance of records that will be requested during an inspection and specifying a window of time for investigators to conduct the onsite inspections. But industry experts are of two minds as to whether any substantial changes will result from the new law. Also: FDA device center Director Jeff Shuren weighs in.
Device companies have an opportunity to leverage several major reforms and initiatives that are getting off the ground related to global facility inspections. But firms must constructively engage with the new programs to reap benefits, say Akin Gump attorneys and former top US FDA officials Nathan Brown and Howard Sklamberg in this guest column.
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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