Quality is often misunderstood. More specifically, the benefits of a well implemented quality management system (QMS) are not universally known…
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Quality Magazine recently published an article “A Risk Based Approach For Medical Device Quality Management” written by Anne Holland, CEO and…
Recently one of our Consultants, Amber Hilfiger, Director of Operations and Senior Quality Engineering Consultant presented to the newest cohort…
Austin, TX, May 19, 2017 – QA Consulting announced today that it has received ISO 13485:2016 certification to provide medical…
The FDA issued a long-awaited final guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part…
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…
