Topics

  • Competent authority views on managing MDR clinical study applications
  • Notified Body assessment of clinical study strategies
  • Industry view on implementation of MDR clinical study requirements
  • International standard for conducting medical device studies: revised ISO 14155
  • International standard for conducting IVD clinical performance studies: ISO 20916:2019
  • Clinical Investigation Plans that meet regulatory and operational requirements
  • Key statistical elements of a successful clinical study
  • Critical considerations in site selection and subject enrollment
  • PMCF investigations, regulatory requirements and practical considerations
  • New medical device clinical safety reporting requirements
  • Investigator-initiated studies, new requirements, new considerations
  • Effective compliance with clinical study-related European privacy requirements