What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.

An important facet of AI regulation is where in the supply chain AI should be regulated—specifically, whether to regulate the developers (builder) or deployers (user) of AI.

The pathway allows medicine developers to work with the regulators, the NHS and health technology assessment bodies.

The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...

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 ...

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 ...

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...

CMS has accepted EBR's WiSE cardiac resynchronisation therapy (CRT) system into the fast-track TCET reimbursement pathway. ..

DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training ...

Research spanning more than 20 years has led the UPV/EHU's Neurochemistry and Neurodegeneration group under Dr. Rafael Rodríguez-Puertas to discover a promising avenue for the development of new ...