[Skip to content]

NHS
Loading
.

Design for patient safety: user testing in the development of medical devices

Reference number
1184
Issue date01 March 2010
TypeGuidance
 This guide will help you to carry out user testing; a vital step in designing for patient safety. It will tell you:
 
  • what factors to consider when designing user testing
  • how to interpret the results
  • the information that should be available for purchasers or users of the device so that they can understand the testing that has been carried out.

The user testing described in this guide is not a compulsory requirement for new devices; it is advice on how best to conduct the testing that is necessary to comply with existing regulations and standards.


The guide will help you to:

  • plan a user testing study
  • identify the safety and usability issues relevant to your specific device
  • specify the design requirements for the safe use of the device
  • make decisions on which users to include in the testing and which methods to use
  • make decisions on what compromises may be necessary – a trade-off will usually have to be made between the benefits of extra user testing and the time and resources available
  • be aware of the ethical, and research and development requirements for user testing studies;
  • collect necessary data to meet usability regulations and standards
  • produce documented evidence of your testing

Design for patient safety: user testing in the development of medical devices
Design for patient safety: user testing in the development of medical devices - 1.04 MB This guide will help you to carry out user testing; a vital step in designing for patient safety. It will tell you what factors to consider when designing user testing; how to interpret the results; and the information that should be available for purchasers or users of the device so that they can understand the testing that has been carried out.