North American NRTL Certification Marking on Medical Devices

Compatible Electronics is always expanding and improving to serve our customers' needs. We strive to be the one-stop shop for NRTL on Medical Devices.

 

Recently we completed our application and standards scope to partner with an NRTL Safety Agency.  We are now able to offer Testing, Evaluation and Help with applying the North American NRTL Certification on Medical Devices (ANSI/UL/CSA 60601-1) under the Data Acceptance Program. 


If your device requires NRTL marking, we can provide the following:


Perform a construction evaluation, perform the applicable safety tests, provide a test report, submit the Test Results, Device Evaluation and Device Information Package to the NRTL Agency.   The NRTL Agency will then review the package and grant permission to apply the North American Certification/Canadian Mark to the Medical Device.


We will continue to provide our standard IEC 60601-1, AAMI ES 60601-1 and IEC 60601-1-2 for FDA 510k review and international markets.


Please contact us for further details if this would be a benefit to serve you better.

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