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Lessons learned on CDx study submissions under IVDR

by Amanda Ball

Join and learn from ARCs experts on their experience with CDx submissions under IVDR regulation.
What you'll learn:
✅ Reclassification and routes to conformity
✅ Experience with IVDR Performance Evaluation 
✅ Clinical testing requirements 
✅ Increased importance of post-market surveillance
Questions? Let's address your pain points: [email protected]

Amanda Ball
Article written by Amanda Ball
November 28, 2023

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