Deadline nears for compliance with new electrical medtech standard

05/20/2013 | MassDevice.com (Boston)

Makers of new electrical medical devices will need to demonstrate compliance with the ES 60601 3rd Edition, effective June 30, under a new FDA requirement. Compliance applies to submissions for 510(k) clearance, premarket approval or other medtech registration programs as well as companies' quality management programs and design controls.

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MassDevice.com (Boston)

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