ACCESS RECORDING

In this on-demand webinar, join experts from Quanterix as they outline strategies for streamlining performance study submissions, aligning with regulatory requirements, and accelerating timelines for submission and approval across individual countries. Learn how Quanterix’s proven experience and collaborative approach can simplify the process while ensuring high-quality results. Whether just starting an IVDR process or optimizing ongoing studies, this session will provide actionable insights to drive readiness and success.

What you will learn:

• Gain a clear understanding of when a performance study is required and how IVDR regulations impact biomarker use.
• Learn the key elements of a compliant submission, from assay validation to regulatory documentation.
• Discover best practices for synchronizing sample collection, data analysis, and regulatory timelines.
• Get insights into efficient workflows, risk mitigation strategies, and tools to accelerate regulatory approvals.
• Learn how our experience, precision, and tailored approach can help you avoid delays and ensure compliance.
• Understand realistic timeframes and how to start your EU IVDR performance study with confidence.

Speakers:

• Brian Ciccariello, VP, Quality and Regulatory Affairs
• Christina Raso, Program Manager

ACCESS RECORDING