PharmiWeb.com - Global Pharma News & Resources
26-Feb-2020 - 27-Feb-2020

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

  • Location:
    • The Rembrandt Hotel
    • Thurloe Place
    • London
    • Greater London
    • SW7 2RS
    • United Kingdom
  • View on a map

This seminar provides an essential overview of medical device clinical evaluations, clinical investigations and post-market clinical follow-up (PMCF) studies with particular emphasis on the adverse event reporting requirements during these studies. The course will concentrate mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives. It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period. It also covers the new requirements regarding periodic safety update reports (PSURs) and the summary of safety and clinical performance.