QA Consulting often advises companies to generate quality plans to ensure that projects are implemented in an organized and comprehensive…
Read More
Author: Anne Holland, CEO and Founder In 2022, 14% of all medical device FDA 483s were attributed to design control...
Read More
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…
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…
Are You Late to the Game? Fourteen months ago, the updated “BS EN ISO 14971:2012 Medical Devices – Application of…
5 Elements for Success Medical device manufacturers are facing increased customer and regulatory scrutiny regarding process validation. Process validation is…
