HiMedia is dedicated to maintaining high safety, quality, and performance standards for in-vitro diagnostic products used in healthcare. This commitment significantly enhances the well-being of ...

Regulatory milestone validates the SOPHiA DDM™ Platform as diagnostic tool in select markets BOSTON and ROLLE, Switzerland, Aug. 14, 2024 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native ...

SAN DIEGO, May 11, 2023 /PRNewswire/ -- "Today we are pleased to announce that Invivoscribe's LeukoStrat ® CDx FLT3 Mutation Assay has been approved by BSI (Netherlands) and the EMA as a Class C CDx ...

The European Commission’s (EC) delays to the implementation of the in vitro diagnostic regulation (IVDR) are creating a drag on IVD innovation in Europe, a regulatory expert has said. Introduced in ...

Venlo, the Netherlands, May 14, 2024 (GLOBE NEWSWIRE) -- QIAGEN (QGEN) (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced an updated version of its clinical decision support platform, QIAGEN ...

NEW DELHI, INDIA, December 11, 2025 /EINPresswire.com/ -- I3CGLOBAL, a leading global regulatory compliance consulting organization, has issued an urgent industry ...

SHANGHAI, Oct. 11, 2023 /PRNewswire/ -- Shanghai Kehua Bio-engineering Co., Ltd ("KHB" or "the Company", Stock code: 002022.SZ), China's leading In Vitro Diagnostic (IVD) company has achieved a ...

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" ...

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 ...

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 ...