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MRC Holland Gets CE-IVDR Certification for Spinal Muscular Atrophy Tests
The company has received certification under Europe's In Vitro Diagnostic Regulation for a number of tests recently.
Biomerica achieves IVDR certification in European union
Biomerica (BMRA) announces that its food intolerance products for Crohn’s Disease and Ulcerative Colitis have achieved CE-marking under the ...
pharmaphorum3d
Pharmacogenomics and IVDR: Overcoming transition challenges
After several high-profile scandals surrounding medical devices, where irresponsible manufacturers’ malpractice in cutting corners showed how easy it was to abuse the Directive, the IVDR came ...
Med Device Online4d
Mastering EU MDR & IVDR: Certification Compliance For Medical Device Importers And Distributors
Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the ...
healthcare-in-europe.com9d
IVDR certification for breast and ovarian cancer assays
MRC Holland recently announced that five SALSA MLPA assays for the detection of hereditary breast and ovarian cancer (HBOC) ...
Kauppalehti8d
Aiforia secures IVDR certification, paving the way for expanded clinical portfolio in Europe
Aiforia® Prostate Cancer Gleason 4 Cribriform and Perineural Invasion (PNI) AI models assist pathologists in detecting these patterns in whole slide images (WSI) of prostate tissue. These AI models ...