Human Factors and Usability Engineering Combo


Fulfill global requirements for Medical Device Usability!

Medical devices have become more and more diverse in their capabilities and are used with increased frequency in busy environments with new distractions and requirements for specialized training. As patient care evolves and is transferred to private homes or public environments, less skilled or even unskilled users including patients and caretakers must be enabled to safely use of these complex devices.

To meet current and future stringent regulatory requirements, human factors and usability engineering must be planned, implemented and verified into the product design and development from the concept phase to the final validation of the device and even within the post-market phase.

IEC 62366-1 is a process-based standard that aims to help manufacturers of medical devices ‘design in’ usability and ‘design out’ use errors. It is recognized as a consensus standard by the FDA and is harmonized by the European Union. The checklist and the SOP provide a convenient way to understand and meet IEC 62366-1 requirements.

You get the following to ensure perfect compliance with IEC 62366-1 and FDA expectations for Medical Devices (incl. SaMD):

  1. A detailed and comprehensive checklist to help you identify gaps against IEC 62366-1. This standard contains general human factors and usability engineering requirements for medical devices.
  2. A detailed procedure to help your design team understand general requirements and regulator expectations for human factors and usability.
SKU: SP-HFUEC Category: