Usability Testing of Medical Devices – IEC 62366

Usability testing of medical device as per IEC 62366 is now a common requirement for CE marking or USFDA registration.

The focus of this standard is to analyze the Normal Use and Abnormal use of the medical device. This is done in close association with Risk Analysis as per ISO 14971.

A manufacturer is expected to develop and maintain a Usability Engineering process  which will start with the identification of list  of Use Specifications.

A Use specification should have the following:

  • Intended medical Condition
  • Intended Patient Population
  • Intended part of the body or type of tissue applied to or interacted with
  • Intended USER PROFILE

A good starting point could be to start identifying the USER PROFILE which can use the medical Device for Use/Installation/Transportation/Repair/Calibration/Disposal.

Each User scenario is then tested with a mix of user profile through their interaction with user interface( elements of medical device that require manipulation )  SO there exists a close relationship between a Successful USER scenario and USER interface – for Successful operation.

IEC 62366 usability testing
IEC 62366 usability testing

ITC India is having Training Usability Engineer with experience of Medical Device testing to handle your requirement of usability Testing. We expect a good Risk Analysis from the manufacturer.