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Platomics has developed the PlatoX platform to automate regulatory compliance processes in the in vitro diagnostic sector. The company’s solution supports laboratories and manufacturers with IVDR compliance by providing workflow documentation, guidance, secure data management, and a regulatory knowledge base. The system is ISO 13485-certified since 2018 and operates from an ISO 27001-certified data center in Vienna. No clinical trial results are relevant as this is not a drug/device developer but rather an infrastructure/platform provider.
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