QA Consulting’s CEO and Founder, Anne Wilson, recently presented on the topic of Current Trends in FDA Inspections for the…
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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…
Everything we know is based on the proposed rule, said Judy Bunch. However, FDA has provided hints to what changes…
