Are You Late to the Game? Fourteen months ago, the updated “BS EN ISO 14971:2012 Medical Devices – Application of…
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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…