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Quality Control & Compliance

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Compliance Corner: Suppliers Can Wreak Havoc On Process Validation Outcomes. Here Are 4 Ways To Keep Them In Check

Having a stellar supplier qualification program in place can lessen the variability in a device-maker's validated processes, says industry expert (and former FDAer) Ricki Chase. She notes that using tools such as questionnaires and onsite audits to determine the suitability of vendors, as well as requalifying and monitoring suppliers of components and services, is essential. "Suppliers can affect your validation activities. Suppliers can completely destroy everything you've put a lot of hard work into," Chase says.

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Latest From Quality Control

BD Handed US FDA Warning Letter In Lead-Test Investigation

The agency letter cites quality systems, Medical Device Reporting and device clearance concerns. It stems from an ongoing investigation into lead tests distributed by Magellan Biosciences that sometimes give faulty results.

Quality Control Regulation

Compliance Corner: When Should Your Firm Revalidate Under Process Validation? An Expert Explains

Conducting process validation activities isn't a one-and-done deal for device-makers; rather, they must revalidate manufacturing processes from time to time, and when necessary. QA/RA expert Mark Durivage highlights an array of situations that could trigger the need for revalidations.

Compliance Quality Control

9 Device-Makers Wanted For US FDA Pilot Program To Measure Quality System Maturity

US FDA is looking for nine medical device firms to enroll in its Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which will use third-party Capability Maturity Model Integration (CMMI) appraisers to evaluate a company's quality system maturity as a view into whether it is operating above a compliance baseline.

Quality Control Compliance

Machine Vision’s Promise For Medical Device Quality

Sure, the human eye is amazing, but there could be problems if it must inspect hundreds of manufactured parts per minute. So, just short of hiring the Six Million Dollar Man or Bionic Woman, what can device-makers do to ensure that all parts are of the best quality? It all starts with machine vision, say Vantage Consulting Group's Vito Pirrera and John Jordon in this guest column.

Manufacturing Quality Control

FDA Asks For More Summary Adverse Event Reports Under Proposed MDR Program

The US agency has proposed a Voluntary Malfunction Summary Reporting Program that will allow makers of an array of devices to submit Medical Device Reports in a summary, rather than individual, format to FDA. The program aims to make the MDR-reporting process more effective and give the agency clearer post-market visibility.

Safety Quality Control

Compliance Corner: 5 Key Steps To Reassessing Management Reviews At Your Firm

Abbott Laboratories' quality VP, Monica Wilkins, outlines five steps that device-makers should take when reevaluating their management review process to make sure they get the most out of the meetings.

Compliance Quality Control

US FDA Pilot Program Speeds Off-The-Shelf Software Validation

The Computer System Validation pilot program is exploring ways for device manufacturers to save time in implementing new information technology tools that support quality systems and other operational functions. One strategy under review: letting companies rely on software manufacturers’ own validation for low-risk functions. Also: A quality assurance manager at device-maker Zoll Medical weighs in on his company's participation in the pilot.

Manufacturing Quality Control

Compliance Corner: FDA Wants You To Take These 5 Actions After A Facility Inspection

US FDA's Sean Boyd says what happens after an inspection is over is just as important as what happens before and during one. Here he lists five critical post-inspection activities that device-makers should keep in mind.

Compliance Quality Control

Device Week, Dec. 6, 2017 – How Investigator Familiarity Breeds Recalls, Poor Quality

On this week’s podcast, we highlight an eye-opening study that shows that the chummier a device-maker is with US FDA investigators, the more likely it is that those firms will experience quality system troubles and face costly product recalls.

Device Week Quality Control
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