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

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

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

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.

Reuters, the news and media division of Thomson Reuters, is the world’s largest multimedia news provider, reaching billions ...

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

EQS-News: aap Implantate AG / Key word (s): Regulatory Approval/Miscellaneous Progress in the MDR process - aap receives MDR certificate 27.01.2025 / 14:00 CET/CEST The issuer is solely responsible ...

CDSCO halts imports of refurbished medical devices in India, sparking debate over impact on healthcare industry.

On January 21, 2025, the Council of the EU adopted the European Health Data Space Regulation (the “EHDS Regulation”). The EHDS Regulation aims at making cross-border exchange and access to EU health ...

Two U.S. companies teamed up to treat cancer patients using an unproven blood filter in Antigua, out of reach of American ...

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

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