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This infographic explains the Notified Body Confirmation Letter for availing MDR extension, transfer agreements, and the compliance process for medical device m...

Incorporation of ISO 13485:2016 into U.S. Regulations: A Strategic Move for Medical Device Manufacturers ...

The class D IVD medical device under In Vitro Diagnostic Medical Device Regulation (IVDR) which encompasses the highest risk in the IVD devices. ...

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Entering the EU (European Union) under the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)...

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