The "A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Apr 29, 2026)" training has been added to ResearchAndMarkets.com's ...
Mechelen, Belgium, 10 March 2026 – Today, Biocartis announced that its Idylla™ CDx MSI Test has received Class C companion diagnostic ( CDx) certification under the EU’s IVDR1 as a CDx for colorectal ...
IVDR compliance is a critical milestone not only for regulatory readiness, but for the long-term sustainability of ...
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" ...
Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced that a broad portfolio of its Alethia molecular assays has ...
Biosynex SA (FR:ALBIO) has released an update. Biosynex SA, a French health diagnostics group, has successfully acquired their first CE markings under the new IVDR regulation for a range of in vitro ...
BOSTON and ROLLE, Switzerland, Aug. 14, 2024 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, today announced ...
Dxcover, a global leader in AI-enabled technologies, today announced that its breakthrough liquid biopsy medical device has successfully achieved CE marking under the European In Vitro Diagnostic ...
The European Commission (EC) has proposed another delay in the compliance deadlines for the In Vitro Diagnostic Regulation (IVDR) that eases the existing timelines by roughly two and a half years. The ...
Seegene certifies diagnostic assays for digestive, respiratory, women's diseases, and human papillomavirus to meet IVDR requirements New regulation sets improved standards to ensure higher level of ...
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" ...
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