Talk Stream B: In Vitro Diagnostics Performance & Validation track
Designing a smarter PMPF for intended purpose and performance claim evolution
Tue, Jan 27, 2026 · 12:00–12:30 PM CET Holiday Inn Munich City Centre
About this session
- Planning modular PMPF studies to generate evidence supporting claim refinement, new use settings, or population expansion
- Addressing gaps from initial submissions and identifying operational challenges
- Leveraging AI tools to streamline post-market data collection, identifying emerging risks earlier, and improving interpretation of real-world performance
- Using PMPF outcomes to support intended purpose expansion and/or claim updates
Speaker
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