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 ...

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

Arterex said the deal expands its capabilities in medical device development, finished device assembly and packaging to ...

In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...

Modular Medical (MODD) announced that BSI Group will serve as the notified body for the European regulatory clearance process. Unlike the U.S.

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 ...

Medical Device Market Size was estimated at USD 335428.32 million in 2024 and it is expected to grow from USD 354883.17 million in 2025 to USD 397243.44 million by 2033. The Market CAGR (growth rate) ...