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

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 ...

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.

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

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 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, ...

A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA). A suite of guidance ...

The medical devices industry representatives said permitting such imports, despite the availability of similar products ...

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

The import of refurbished medical devices—largely high-tech equipment like MRIs, CT scans, and surgery robots—has been a ...