This is the first of an ongoing series to help medical device manufacturers and labelers better understand the Unique Device…
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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…
Takeaways from the FDA Small Business Regulatory Education for Industry (REdI) Conference QA Consulting attended the FDA Small Business Regulatory…
Everything we know is based on the proposed rule, said Judy Bunch. However, FDA has provided hints to what changes…
