When conducting a clinical investigation, meeting regulatory requirements is predicated on factors such as the quality of ...

Medical device regulation and safety are critical components of healthcare, ensuring that devices used in medical settings are safe and effective for patient use. Recent research has highlighted ...

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

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.

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 ...

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

Guilford-based Hyperfine, which had 131 workers as of February 2024, is laying off 14% percent of its workforce.

The MHRA has issued fresh guidance to help medical device manufacturers prepare for upcoming regulatory changes.

“The new Post-Market surveillance regulations will provide us with more safety information on medical devices in use in GB, ...

Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments ...