The adoption of MDR and IVDR presents opportunities for businesses to adapt to rigorous regulations, gaining market access by staying compliant. Experts can leverage insights on UK regulatory changes ...
The request includes a call to postpone re-certification requirements for devices already certified under the medical ...
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" ...
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 ...
Beckman Coulter Life Sciences, a global leader in laboratory automation and innovation, is leading the way to help laboratories prepare for critical upgrades to comply with the new In Vitro Diagnostic ...
Yourgene Health (part of the Novacyt group of companies), a leading international molecular diagnostics group, announces that it has received accreditation under the new EU requirements of the in ...
NIJMEGEN, Netherlands--(BUSINESS WIRE)--Aiosyn, a pioneering innovator in AI-powered pathology software for cancer and kidney disease, has announced that its algorithm for mitotic figure counting has ...
Drawing a positive conclusion about the IVDR: Sales Representative Dr. Thorsten Heinlein, CEO Dr. Erdmann Flindt, COO Dr. Carsten Stollfuß, and Laboratory Manager Dr. Jessica Walkowiak. The Aamino a ...
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