QA Consulting has identified a shift in perception within the medical device industry regarding FDA inspections in recent years. Specifically,…
Two new sections were added to FDA’s 21 CFR (Code of Federal Regulations) with the release of the Unique Device…
QA Consulting often advises companies to generate quality plans to ensure that projects are implemented in an organized and comprehensive…
In our first article on Unique Device Identification (UDI we noted the UDI compliance deadlines set by the FDA that are…
If you did not get the chance earlier this month to attend one of Anne Wilson’s presentations on Current Trends…
QA Consulting’s CEO and Founder, Anne Wilson, recently presented on the topic of Current Trends in FDA Inspections for the…
This is the first of an ongoing series to help medical device manufacturers and labelers better understand the Unique Device…