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.

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

Arterex, a global medical device design, development and contract manufacturing company, has acquired Phoenix S.r.l., a ...

Medical Device Regulation (MDR): A set of regulations in the European Union that governs the approval and monitoring of medical devices to ensure safety and efficacy. This Nature Research ...

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms ...

Cybersecurity has become a leading priority for manufacturers of embedded systems and IoT devices. The rapid proliferation of ...

Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need ...

The HPRA is the national regulator across many different health products: medicines, particularly pharmaceuticals and ...

Pharma and medtech companies are invited to join a project on PFAS exposure, emissions and end-of-life management in the ...

Fourth-quarter sales of $11.0 billion; full-year 2024 sales of $42.0 billion Fourth-quarter reported sales increased 7.2 percent; organic sales growth for the underlying ...