Swiss data company Sophia Genetics has secured a CE mark for its genomic analysis platform under the EU’s revised In Vitro Diagnostics Regulation (IVDR). The IVDR CE mark certifies that the company’s ...
OSLO, Norway, March 31, 2026 /PRNewswire/ -- DNV, a designated Notified Body for the European Union's In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR), has been selected by a ...
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 ...
Venlo, the Netherlands, May 14, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced an updated version of its clinical decision support platform, QIAGEN ...
Laura Nea, Vice President of Quality & Regulatory Management at Tecan (Männedorf, Switzerland), discusses the benefits and challenges of transitioning to in vitro diagnostic regulation (IVDR) and ...
Medical Device Network on MSN
EU AI Act meets MDR/IVDR: clarity or chaos?
Observers anticipate that the EC’s proposal to harmonise the AI Act’s tenets for medical devices with the MDR/IVDR could be ...
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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results