Beta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...

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.

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 ...

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

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

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

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) ...

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

The FDA is particularly concerned that supply chain issues are having an adverse impact on neonatal and paediatric patients.

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

Expert warns that In future, smart-connected devices must comply or it will be illegal to sell them in the European Union ...