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 […]» Read more
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 […]» Read more
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 […]» Read more
FDA Part 11 for Medical Device Manufacturers: Are You Complying With These Four Critical Requirements?
The first paragraph of 21 CFR Part 11 seems disarmingly straightforward. It says: “The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.” So simple…or so it seems. But as you are discovering, the “devil is in the details.” The Top Four Part 11 Compliance Requirements for Medical Device Companies […]» Read more