Near-patient testing (NPT) devices face substantial challenges under the new IVDR, including: New Stringent Regulatory Constraints due to IVDR Risk-Based Approach for Usability and Human Factors, including Use Environment Expectations from Notified...
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Nicolas Borenstein, DVM, Ph.D. Co-President, Preclinical Services “We are not a veterinary clinic and our primary mission is indeed to validate...
In this white paper, our regulatory team presents the frameworks governing Laboratory Developed Tests in Europe and the USA, and discuss important...
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Recently two Veranex employees volunteered their time and expertise to IFPx — a company working on a device to monitor and proactively treat heart...
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How Clinical Teams Are Replacing Firefighting With Future-Proof Monitoring The Silent Efficiency Leak: Why Legacy Systems Fail In 2024, a study of...
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