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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.
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Biomerica Achieves IVDR Certification for Food Intolerance Products in European Market
Biomerica, Inc. has achieved IVDR certification for its food intolerance products designed for managing Crohn's Disease and Ulcerative Colitis, marking a significant step in compliance with ...
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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 ...
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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 ...
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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) ...