This one-day intensive course enables manufacturers to learn about the key requirements, concepts and the overall process for post-market surveillance and vigilance under the MDR and IVDR.

BSI’s ‘Post-market Surveillance and Vigilance under the Medical Device Regulation (MDR) and In Vitro Diagnostics Medical Devices Regulation (IVDR)’ one-day training course has been designed to provide manufacturers with the tools to implement an appropriate system for gaining and reviewing experience in the post production phase from the range of devices they manufacture.

How will I benefit?

The course will help you:

  • Understand the key requirements and concepts of the post-market surveillance and vigilance for the MDR and IVDR
  • Gain sufficient understanding to be able to write your PMS and vigilance procedures
  • Communicate the impact of these key requirements introduced by the MDR and IVDR to your organization
  • To obtain essential knowledge to implement a compliant post-market surveillance and vigilance quality management system
  • To understand how the PMS and vigilance processes integrate into the quality management system 
The course was delivered in a clear manner and easily understood.