Medical
Rhein Tech Laboratories, Inc. (RTL) tests electronic medical devices for Product Safety and EMC to both national and international standards such as FDA 510K (USA), EN60601-1 (EU), and EN60601-2 (EU). Medical devices require EMC and product safety testing to provide patient safety. In the US, the FDA regulates Medical device testing and in Europe, electronic Medical devices must comply with the Medical Device Directive (MDD). Electronic Medical devices are tested in accordance with EN60601-1/2. When a device specific test plan is required, RTL collaborates with our Notified Body to develop the specific test plan. Our test data including other related documents is submitted to the Notified Body to prepare a Technical Construction File (TCF).
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Rhein Tech Laboratories, Inc.
360 Herndon Parkway, suite 1400
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