This session will explore the critical aspects of demonstrating analytical performance, a cornerstone of IVD device evaluation under IVDR and other global regulatory frameworks.

Through expert insights and practical examples, you will gain a clear understanding of:

Key analytical performance parameters: including sensitivity, specificity, accuracy, precision, linearity, limit of detection (LoD), limit of quantification (LoQ) and analytical specificity
Study design considerations: how to structure robust analytical performance studies that meet regulatory expectations
Common pitfalls and how to avoid them: lessons learned from real-world assessments
Documentation and reporting: aligning evidence with IVDR requirements and technical documentation standards
Interfacing with notified bodies: strategies for presenting analytical performance data during conformity assessment procedures

This webinar will equip you with the knowledge and tools to confidently demonstrate analytical performance and support successful regulatory submissions for your IVD medical devices.

Agenda

Introduction
What is analytical performance
Regulatory requirements
Key analytical performance parameters
Studies to support analytical performance
Documenting analytical performance
Common issues observed by notified bodies
Best practices
Summary
Questions & answers

Target Audience

The webinar is intended for:

In vitro diagnostic medical devices manufacturers worldwide, including corporations, SMEs and startups
Persons responsible for regulatory compliance (PRRC)
EU authorized representatives, regulatory affairs managers and their teams
Quality managers and their teams
Technical directors and their teams
R&D managers and their teams
Validation managers and their teams.

Language: English

Cost: No charge

Can't make a live session? Register now and receive a complimentary recording after the live event.