Usability Engineering IEC 62366-1:2015

Application of usability engineering to medical devices

Application of usability engineering to medical devices

virtual classes schedule

Awareness Training Program based on Usability of Medical Devices according to IEC 62366 | Time: 9:30 am to 5:30 pm

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In today's day and age, medical devices are increasingly becoming complicated. To eliminate user errors, there's a need to create more user friendly devices. Medical devices can be made more intuitive with usability engineering. IEC 62366-1:2015 defines a process through which a medical device manufacturer can analyse, specify, develop and evaluate the usability of a medical device with relation to safety. This process helps the manufacturer analyse and reduce the risks associated with the normal use of the medical device. This standard also enables the manufacturer to identify the risks associated with the abnormal use of the device. It also helps manufacturers to improve the device's usability by setting out an appropriate usability engineering process.  

This 2 days course will be conducted by our experts, which will comprise of tutor-led sessions, discussions, exercises and case studies to ensure that the delegates are equipped with the knowledge and understanding of standard requirements and skills to implement it effectively in their organization.


This course will help you to 

  • Understand key parts of IEC 62366-1
  • Gain insights about the standard from our experts
  • Terminology and compliance requirements


  • Key parts of IEC 62366-1
  • Written for easier to understand intent / implementation
  • Closer ties to ISO 14971, Medical Device Risk Management
  • Closer adherence to US FDA guidance; more harmonization
  • Planning requirements
  • Defined engineering process
  • User interface considerations


Senior Management, Middle Management, QA/RA, Operations, Production, Engineering, Marketing and Medical Device Consultants

Training Duration

02 Days


Participants will be assessed throughout the course for punctuality, presentation skills, their involvement in classroom exercises and finally through a written examination (open book) at the end of the course. Minimum passing% criteria: 70%.

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