From Compliance to Success: How to Create Efficiency and Effectiveness in EU IVDR Readiness for Clinical Studies
On-Demand Recording
Navigating EU IVDR requirements for clinical studies can be complex, but with the right strategies, you can streamline submissions and accelerate approvals. In this webinar, Quanterix experts share insights on optimizing performance study submissions, ensuring compliance, and reducing regulatory bottlenecks.
What you’ll learn:
- When a performance study is required and how IVDR regulations impact biomarker use
- Key elements of a compliant submission, from assay validation to regulatory documentation
- Best practices for aligning sample collection, data analysis, and regulatory timelines
- Strategies to mitigate risk and accelerate regulatory approvals
Gain the knowledge and confidence to navigate EU IVDR with efficiency.
Complete the form to access the on-demand recording.