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

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

AI was a key theme at OCT Medical Devices 2025, yet human sensibility appears to be the true differentiator in clinical trial ...

What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.

Precise, high-quality silicone is essential for medical devices like catheters, surgical tools, prosthetics and long-term ...

CEO Scott Whitaker said “an exemption was provided for most medical devices during President Trump’s first term with respect ...

The MHRA has issued fresh guidance to help medical device manufacturers prepare for upcoming regulatory changes.

The FDA's mandate responds to a long-standing concern and offers a solution to the frustrations CIOs have expressed regarding the lack of security requirements from medical device manufacturers.

The new director of the FDA’s device center contrasted a European rule with the lack of mandatory reporting requirements for ...

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical ...

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