U.S. FDA to require proof of IEC 60601-1 3rd Edition in summer 2013

May 20, 2013 by MassDevice

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.

Global Medicine

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration will begin requiring manufacturers and sponsors of electrical medical devices to show compliance with the standard ES 60601 3rd Edition starting June 30, 2013.

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