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

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

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

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

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 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 ...

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

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 ...

New Delhi: In an attempt to bring regulatory uniformity in medical devices, the government plans to classify around 1,178 medical devices into four categories based on their risk approach under ...