QA Standards for IEC 62366

by itsbusiness AG

The international standard IEC 62366 medical devices - Application of usability engineering to medical devices is a standard which specifies usability requirements for the development of medical devices.

IEC 62366 is the international standard that covers the application of usability engineering to medical devices. This standard helps medical device manufacturers consider human factors by offering a standardised process for analysing, specifying, developing, and evaluating the usability of their medical device.

IEC 62366 is broken into two parts:

  • IEC 62366-1 - Application of usability engineering to medical devices
  • IEC 62366-2 - Guidance on the application of usability to engineering to medical devices

IEC 62366-2 is a technical report which contains background information and guidance on implementing IEC 62366-1 and does not specify any requirements.

The Johner Instut blog on Usability & IEC 62366-1 has further information.


The usability engineering process found in IEC 62366 consists of a series of steps to ensure that the UI of a medical device has been rigorously evaluated for user and patient safety:

  • Define intended users, use environments, and user interface.
  • Identify use-related hazards.
  • Identify and categorize critical tasks.
  • Develop and implement risk mitigation/control measures.
  • Validate user safety and effectiveness.
    • If validation shows that use-related risks are unacceptable, or that new use-risks have been introduced, you must return to the previous step and implement effective risk control measures.
  • Document your UE process.

It’s important to note that usability engineering validation of devices takes two forms, formative evaluations, and summative evaluations.

Formative Evaluation

Formative evaluations are conducted while a device is still in design and development. These evaluations are used to address safety concerns that emerge during preliminary analyses or to explore different design options for the UI before it’s finalized. You may end up carrying out multiple formative evaluations.

Summative Evaluations

Summative evaluations are conducted during the design validation stage of a device. A summative evaluation is much more rigorous than a formative evaluation, as its goal is to demonstrate that the UI is safe for users. Testing should involve the intended end users of the device engaging with the final UI design under realistic conditions.

With our experienced consultants, including staff who have developed and tested safety critical software, itsbusiness supports you in the development of robust software quality assurance, carries out an assessment together with you for a TARGET/ACTUAL analysis, and submits an action plan as well as for the implementation. Within the scope of the implementation, we support you in the implementation of the action plan and ensure the achievement of the objectives.


If you have questions or need more information, please contact:

Andrew Connell
QA Consultant, itsbusiness AG
+41 31 370 32 05​

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