- Translating past performance data into IVDR-compliant clinical evidence
- Substantiating full intended purpose claims across settings and populations
- Avoiding delays by proactively identifying outdated or missing data
- The impact of AI and cyber threats on medical devices
- The new cyber challenges 2026 may bring
- How regulators and tech companies are coming to terms with the AI challenge
- Early IVDR‑aligned planning ensures compliant trials and robust validation
- Harmonize multiple CDx pathways to optimize sample use and ensure consistent evidence across regions
- Strong Rx–Dx collaboration is essential for analytical and clinical validation throughout development
- Comparing clinical evidence expectations for ophthalmic devices across Asia and Europe
- Highlighting key differences in PMCF interpretation and execution under EU MDR
- Sharing real-world challenges when translating Asia-generated data for European submissions
- Identifying common gaps and misconceptions in cross-regional evidence strategies
- Providing actionable learnings for building sustainable, MDR-aligned clinical and PMCF programs
- Design trials that support both CE marking and joint clinical assessment
- Anticipate decision makers’ expectations when choosing clinical endpoints
- Avoid duplication of evidence generation by aligning early
