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Quality Control & Compliance

Set Alert for Quality Control

Analyzing Quality Data Is Essential. Here’s What One Expert Says Your Firm Should Do To Stay In FDA’s Good Graces

Device makers should make sure they have adequate resources to analyze quality data they take in so they can prevent the recurrence of nonconforming products, processes and procedures. That’s just one nugget of advice from former FDA investigations branch director Ricki Chase, who explains why collecting and properly handling such data is critical to complying with agency expectations in this Medtech Insight Q&A interview.

Quality FDA Compliance

Latest From Quality Control

Warning Letter Roundup & Recap – 3 December 2019

In the only device-related warning letter released by the US FDA this week, a manufacturer of surgical trays and kits was cited for quality systems violations.

Device Week FDA

Warning Letter Close-Outs – November 2019

The US FDA released one device-related close-out letter in November.

Device Warning Letters FDA

How Your Medtech Company Can Build Trust With FDA Investigators – And The Agency At Large

Device makers that build bridges with US FDA investigators will have an easier go of things during facility inspections, says Ricki Chase, a former FDA investigations branch director. By doing this, firms can extend that trust to the agency as a whole. Check out our full Q&A with Chase here.

FDA Compliance

Medtronic Warns On Insulin Pump Safety

Medtronic has announced a safety issue in its popular MiniMed 600 series of insulin pumps. The devices may under- or over-deliver insulin if a ring component of the device cracks or breaks, potentially causing serious health issues. The company says the issue doesn’t amount to a recall, however.

Quality Control Safety

Delayed Twice, FDA Now Says It Won’t Release Its Harmonized QSR/ISO 13485 Draft Rule Until April 2020

First it was April 2019, then September 2019 – but both of those deadlines were missed. Now, the US agency has set a target date of April 2020 to release a draft regulation that will harmonize its Quality System Regulation (QSR) with international standard ISO 13485.

Regulation Standards

Close-Out Meetings With FDA Investigators: What Manufacturers Need To Know Before Their Next Inspection

When the US agency comes to inspect a manufacturer’s facility, one of the more important activities that occur is a close-out meeting. Consultant and former FDA investigations branch director Ricki Chase explains why these meetings, held daily or at the end of an audit – or both – can help make or break an inspection.

Compliance FDA

Warning Letter Roundup & Recap – 19 November 2019

A manufacturer of in vitro diagnostic reagents was cited for premarket violations in the only device-related warning letter released by the US FDA this week.

Device Warning Letters FDA

Process Validation Can Be Problematic For Device-Makers. Here’s Why – And What Companies Can Do About It

Medical device manufacturers often stumble when conducting process validation activities. In this Q&A, former US FDA investigations branch director Ricki Chase explains what those hurdles are and offers tips to firms to make sure they’re on the road to compliance.

Quality Compliance

A Softer, Gentler FDA Inspectorate? It’s Possible With QSR/ISO 13485 Harmonization, Auditing Expert Says

Let’s be blunt: Device-makers aren’t particularly fond of facility inspections by the US FDA. From audits that can sometimes drag on for weeks to nightmarish inspections well-documented by industry experts, there’s no shortage of tales of investigators that were difficult to handle. But the agency’s ongoing rewrite of its Quality System Regulation to harmonize it with international standard ISO 13485 could “soften FDA’s inspectorate,” NSF International’s Brian Ludovico says. Also: How might the FDA’s Quality System Inspection Technique (QSIT) change, post-harmonization?

FDA Enforcement
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