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Biocartis

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Biocartis is a molecular diagnostics company focused on developing and commercializing innovative diagnostic tests. The platform centers around a fully automated molecular diagnostics system for personalized medicine applications. Biocartis is based in Mechelen, Belgium.

As an IVD manufacturer in the European Union, Biocartis is subject to the In-Vitro Diagnostic Regulation (IVDR 2017/746). The company must demonstrate compliance with the regulation's requirements for performance evaluation, risk management, and post-market surveillance.

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