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 ...

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

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

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

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

Thousands of companies outside Europe in Asia and America are also affected by the new EU regulation. Duesseldorf / Germany ...

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 ...

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