Design Control

Design Control


Usability of Medical Devices according to IEC 62366-1

Reduce the risk of use errors with usable Medical Devices
and increase safety and performance for patients and users.

The application of Usability Enineering to Medical Devices is closely linked to Risk Management and deeply rooted in the fundamental safety and performance requirements of the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). The FDA also places requirements on what it calls "human factors engineering".

Usability Engineering aims to reduce the risks caused by use errors as far as possible by taking into account, for example, the technical knowledge, experience and training, and further education of users.

IEC 62366-1 can be used to fulfill the regulatory requirements. This standard describes the requirements for a Usability oriented development process.

Frequently asked questions about the development of Medical Devices in terms of Usability - Sound familiar?

The Medical Device is completely developed and "all of a sudden" the Usability File has to be created?

  • But how should we do this? Using which templates?
  • How is it to be understood in the daily norm?
  • With how many people do I have to carry out the Usability testing so that they are representative?
  • Do I have to do the whole Risk Management again?


  • Do I really need this? My Medical Devices are super safe and easy to use!

We will explore your opportunities

Does your product portfolio contain Legacy Devices , and you would like to follow the UOUP-approach, but you are not sure if you are authorized to do so? Our Usability experts will support you in the breakdown of this strategically important decision.

Contact +49 451 808 503 60

The Usability File

In the Usability file, all documents that prove that you meet the Usability requirements for Medical Devices from IEC 62366 and, if applicable, the FDA, are compiled. How you assemble the file is not specified, but it should at least include the following contents:

  • Extended purpose
  • Specification
  • The user
    • The context of use and
    • The interface of the user Device
  • Verification and validation documents

Usability engineering according to
IEC 62366-1 can be confusing -
We can ease your confusion!

Regardless if you need help with new development or existing Devices we will show you how to compile your Usability file effectively and compliant. Our company will accompany you in any necessary tests for formative or summative evaluation.