When conducting a clinical investigation, meeting regulatory requirements is predicated on factors such as the quality of ...

One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR ...

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS ...

For those with Class IIa or above AI-related devices, compliance with the EU’s AI Act is likely to be akin to the EU MDR.

In large part, this has meant navigating the requirements of the European Union’s Medical Device Regulation (EU MDR). Introduced in 2017, the MDR mandates sweeping regulatory reforms that are ...

STAT covers the development, regulation and use of medical devices. Topics include the safety of medical devices, the challenges of bringing new devices to market and the role of medical devices ...

The EU MDR certification is recognized globally for ensuring that medical devices meet stringent requirements ... and compliance with the highest regulatory standards. Signifier is a pioneer ...