The FDA issued a long-awaited final guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part…
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Medical device manufacturers commonly use outsourced suppliers for device components, assembly, packaging, labeling, and sterilization. An outsourced supplier may even produce…
QA Consulting’s CEO and Founder, Anne Holland Wilson, recently presented on the topic of Efficient Validation Strategies and VMPs for…
Human factors and usability engineering are synonymous terms that describe the application of knowledge about human behavior toward the design…
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…
Author: Anne Holland, CEO and Founder In 2022, 14% of all medical device FDA 483s were attributed to design control...
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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…
