ARLINGTON, Va.--(BUSINESS WIRE)--The Medical Device Innovation Consortium (MDIC) has announced the release of its Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics ...

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "EU MDR and IVDR: Key Updates and Compliance Strategies for 2025 (Aug 6, 2025)" training has been added to ResearchAndMarkets.com's offering. The EU ...

The Council has endorsed key updates to the law on medical devices that will help prevent shortages and ease the transition to greater transparency and access to information. The regulation approved ...

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 Course" ...

Following the identification of several key challenges in the application of the Medical Device Regulation (MDR) and In Vitro ...

This article is the third in Microbiologics’ series on Optimal QC in the Clinical Laboratory. Previously, in this series we highlighted the importance of external and third-party quality control ...

insights from industryLaura NeaVP of Quality and Regulatory ManagementTecan In this interview, News-Medical talks to Laura Nea, Vice President of Quality and Regulatory Management at Tecan, about the ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

The course offers market opportunities by addressing the need for understanding and implementing the role of the Person Responsible for Regulatory Compliance (PRRC) under MDR and IVDR, critical for ...

The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information. The regulation ...