Resources

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Webinar – 2024 IVDR Sprint Series: How to Deal with Regulatory Requirements when Collecting Clinical Performance Data

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Webinar – 2024 IVDR Sprint Series: The Clinical Challenge – Addressing Increased Evidence Requirements in the EU IVDR Era

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...

Webinar: Panel Discussion – FDA’s Regulation on LDTs: Current Impact and Future

In this recorded panel discussion, members of different healthcare organizations discuss the potential impact of the FDA Rule on LDTs, near term /...

Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA

In this white paper, our regulatory team presents the frameworks governing Laboratory Developed Tests in Europe and the USA, and discuss important...

Webinar – 2024 IVDR Sprint Series: Companion Diagnostics (CDx) – Critical Areas and Implications for Successful Development and Launch in the EU

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Webinar – 2024 IVDR Sprint Series: How to Adopt a Proactive Approach to Ensure Timely Compliance with the Applicable Deadlines

White Paper: Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA

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