Archives: Agenda

Q&A session: lessons learned from former Notified Body expert

  • See how to align robust clinical evidence for MDR from an NB perspective
  • Bridge the gap between reviewer expectations and sponsor realities
  • Optimize clinical trial design and submissions for smoother approval

Chair: Dominic Tong, Senior Analyst, Medical Devices, GlobalData

 

Designing a smarter PMPF for intended purpose and performance claim evolution

  • 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

From reactive compliance to continuous evidence: Taking back control of clinical data in medtech

  • Medical device evidence is shifting from one-off trials to continuous, lifecycle-long evidence, with growing emphasis on post-market and real-world data and performance
  • Episodic evidence generation models, designed around isolated studies and outsourced delivery, are increasingly misaligned with these expectations and introduce cost, delay and duplication at scale
  • How medtech teams can use a single, versatile and affordable platform to run feasibility studies, trials, PMS and RWE in-house, enabling faster evidence generation and systematic reuse across the lifecycle
  • A surgical robotics case study showing how clinical trial capabilities are brought in-house and a global clinical registry is leveraged to support evidence generation pre- and post-market

Inside the IVDR performance study review: competent authority insights and practical guidance

  • Tracing the evolution of IVDR governance and how MDCG working groups shaped today’s framework and merged responsibilities over recent years
  • Exploring behind the scenes of performance study assessments, including what is discussed within the competent authority review process and how applications are evaluated
  • Sharing practical recommendations, common pitfalls, lessons learned, and strategies for preparing approval-ready submissions

Why medical device trials need a new EDC architecture

  • How an all-in-one eClinical platform simplifies medical device trial operations
  • Why API-first interoperability is critical for device studies
  • Practical AI use cases that support, rather than replace, clinical teams