dijous, 21 de maig del 2015

Seven mistakes that can delay your FDA 510(k) clearance

The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.

Emergo Group

By Stewart Eisenhart, Emergo Group

Based on data provided by the US Food and Drug Administration as well as Emergo consultants' experience with medical device manufacturing clients seeking US marketing approval, seven major issues have been identified as the most common perennial causes for delayed premarket notification applications.

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