FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Certification Need to Know

For years, US FDA has been talking about aligning the existing FDA Quality System Regulation (QSR) with ISO 13485. FDA has finally taken concrete steps to do so by issuing a draft version of the new Quality Management System Regulation (now called “QMSR”). For US companies that export and have ISO 13485 certification, the update is welcome news. For the roughly 22%* of medical device companies that sell only in the US market, the impact on their QMS will go well beyond […]

Will Your Team Be Ready for a (Live and In-Person) FDA Medical Device Inspection?

COVID-19 significantly curtailed FDA’s ability to conduct surveillance inspections of medical device manufacturers. Most manufacturers have not had an FDA inspector show up at their facility since at least March 2020. However, on July 1, 2021, FDA resumed on-site inspection operations, although it remains to be seen how quickly they’ll get up to speed. There is little doubt that COVID-19 made it more challenging to maintain a quality management system compliant with the FDA Quality System Regulation (QSR). Most non-manufacturing […]

When Will FDA Resume Medical Device Inspections?

Remember FDA inspections? Yes, we know you’ve missed them, and chances are extremely high that’s because an FDA inspector has not darkened your door since early 2020, likely longer. While virtual meetings are the new normal for many business professionals, it’s pretty clear that FDA has begun to transition to live, onsite inspections of domestic manufacturers. But before they can ramp up to full normal inspection operations… …The FDA Has to Dig Itself Out of a Hole As you probably […]

Non-Product Software Risk Assessment for Medical Device Manufacturers

This is the first article of a three-part series on non-product software risk assessment, validation and testing. Download the entire series in one convenient PDF. Part 1: This article Part 2: Non-Product Software (NPS) Validation for Medical Device Manufacturers Part 3: Writing NPS Protocols and Testing for Medical Device Manufacturers Here’s a relationship tip. If one day your spouse or partner asks you what you did today, never reply by saying that you were working on a master validation plan […]

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