White Paper: Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA
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In this white paper, our regulatory team presents the frameworks governing Laboratory Developed Tests in Europe and the USA, and discuss important deadlines, exceptions and the main differences in the way these tests will be overseen on these two continents.
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Webinar – 2024 IVDR Sprint Series: Usability and Human Factors: Cornerstones of Near Patient Testing – Insights and Perspectives from a Notified Body
Near-patient testing (NPT) devices face substantial challenges under the new IVDR, including: New Stringent Regulatory Constraints due to IVDR