Clinical evidence for AI-based medical devices

  • Discussion of approaches to release retrained AI algorithms
  • Case study for notified body pre-approval to retrain AI algorithms
  • Overview of accompanying clinical evidence requirements
  • Impact of AI Act implementation

Adapting trial designs to global market realities

  • Align protocol design with MDR, FDA and global regulatory expectations
  • Manage endpoint variability across geographies without undermining quality
  • Avoid costly rework by building flexibility into trial strategy

 

From PMCF obligation to strategic advantage: standardising PMCF under EU MDR with 1Survey+

  • The reality of PMCF under EU MDR: mandatory, continuous and increasingly scrutinised
  • Common pitfalls in current PMCF strategies and why many approaches no longer satisfy Notified Body expectations
  • Introducing 1Survey+, a clinical-grade, regulator-ready PMCF platform designed in accordance with ISO 14155
  • From fragmented PMCF activities to portfolio-level standardisation and scalability