speciality

MDR (MDR01)


Description
The objective of this course is to present the new regulatory requirements from the medical device regulation 2017/745.
This includes 10 sections detailing the requirements with examples each time this is possible and a quick quizz at the end of each section to check your understanding. You can also contact the administrator in case of difficulty.
The session will remain open for 3 months to give you time to do the training and a test will be at the end of the training for validation of the module.
A certificate will be delivered at the end of the training.
Content
  • introduction and structure
  • introduction and structure
  • changes with the MDR
  • changes with the MDR
  • conformity assessment routes
  • conformity assessment routes
  • general, safety and performance requiremenets
  • general, safety and performance requirements
  • general, safety and performance requirements 1
  • general, safety and performance requirements
  • classification
  • classification
  • classification of the device 1
  • classification of device 2
  • clinical evaluation
  • clinical evaluation
  • clinicial summary
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever