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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…
PRESS RELEASE Austin, TX, May 30, 2014 — (QA Consulting, Inc), a medical device consulting firm, has received ISO 13485:2003…
PRESS RELEASE (Austin, TX) – (October 29, 2013) – (QA Consulting, Inc.), a business specializing in providing quality, regulatory, and…
Top 10 Differences Between the Proposed and Final Rules In June 2013, QA Consulting presented “Unique Device Identifier: Update and…
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…