Resources

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...

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...

1 min read

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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