simple course

Usability according to IEC 62366


Description
This 1 day training course - Usability Requirements - gives participants an in-depth knowledge of IEC 62366 requirements and its application.
It guides organisations through the regulatory requirements for:
active medical devices
non active medical devices
It focuses on MDR and MDD compliance and explains how businesses can guarantee the safety claims of medical devices.
Content
  • Introduction
  • FDA guidance on usability
  • introduction
  • Differences between 2008 and 2015
  • Publication 1
  • Publication 2
  • Differences between 2008 and 2015
  • Specifications
  • requirements of the standards
  • Requirements of the standard
  • requirements of the standard
  • publication on usability report
  • Implementation of the requirements
  • implementation of the requirements
  • report-template-usability-test_0.docx
  • draft a report
  • usability survey
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever