This infographic highlights the launch of the Swissdamed UDI Device Module, explaining its purpose, registration requirements and compliance benefits for Swiss ...

Freyr is a global Regulatory Solutions and services company offering services across the entire regulatory value-chain for Pharmaceuticals, Consumer Healthcare ...

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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