FDA RESPONSIVE TO THE PUBLIC HEALTH RISK ASSOCIATED WITH COVID-19 Author: Anne Holland, CEO and Founder One does not generally…
In the Coronavirus Era You May Experience Your First-ever Remote Audit Author: Amber Hilfiger, Director of Operations and Senior Quality…
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…
Recently one of our Consultants, Amber Hilfiger, Director of Operations and Senior Quality Engineering Consultant presented to the newest cohort…
QA Consulting has identified a shift in perception within the medical device industry regarding FDA inspections in recent years. Specifically,…
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…