In the Coronavirus Era You May Experience Your First-ever Remote Audit Author: Amber Hilfiger, Director of Operations and Senior Quality…
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Important ST72:2019 updates can help ensure successful 510(k) submissions or avoid non-conformances The American National Standards Institute (ANSI) and the…
QA Consulting CEO & Founder Anne Holland is featured in a Quality Magazine article focusing on the challenges medical device…
QA Consulting Hires Consultant Silas Todd Minnick Accomplished quality professional has extensive knowledge in multiple quality functions Austin, Texas –…
Quality is often misunderstood. More specifically, the benefits of a well implemented quality management system (QMS) are not universally known…
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…
