The FDA issued a long-awaited final guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part…
Read More
BLOG
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 which 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,…
Design Transfer is the culmination of a design team’s efforts during which the product and process designs are transferred to…
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…
Research and development of a medical device often takes years of preliminary feasibility studies and false starts before an official…
In our first article on Unique Device Identification (UDI we noted the UDI compliance deadlines set by the FDA that are…
