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15 - 17 June 2021
Virtual EventDelivered in CEST time zone

In Search Of The Fastest Route To Clinical Compliance?

Clinical Development Plans. CER. PMCF. Discover How Your Peers Meeting ‘Sufficient Clinical Evidence’ Requirements Under The EU MDR

Including Practical Insights And Live Q&As With The EU Commission, Notified Bodies and leading industry experts

Tips And Tricks To Meet The Clinical EU MDR Requirements And Minimize Workload

Master Your Clinical Evidence Approach With Valuable Industry Learnings

  • J&J divulge advice for achieving robust strategies for your clinical development plan
  • Ensure best practice to meet the bar of ‘Sufficient’ clinical evidence with MedEL's insights. 
  • Heart Point Global provide practical tips for preparing clinical evaluations for novel devices without equivalence.
  • Hear how Abbott are meeting clinical evaluation requirements with a case study

 

Need A Notified Body Perspective? We Have Lots...

  • NSAI’s Chief Clinical Evaluator for Medical Devices, Dr Yvonne Ndefo, highlights the clinical evaluations expectations, elements observed of successful submissions and common errors.
  • TÜV SÜD’s Global Team Leader + Clinical Focus Team Manager, Dr Matthias Fink, shares experiences and feedback on preparing for the EU MDR  
  • DARE!!’s Clinical and Technical Expert, Natascha Cuper, discusses clinical data and when Article 61.10 can be used.
  • TÜV SÜD’s Clinical Expert/Auditor, Vera Wells, outlines experiences during Clinical Audits and the challenges faced. 

 

Share Clinical Experiences

  • Hear about initial experiences with Expert Panel Groups with Paul Piscoi, Scientific Policy Officer, European Commission  
  • Smith & Nephew help you get to grips with what information is required during clinical trials under ISO 14 1995  
  • Bassil Akra, QUINQUE assesses the Post Market Clinical Follow-Up requirements.
  • Learn about preparing for Clinical Evaluations for novel devices without equivalence with HeartPoint