Human Factors and Usability Engineering Procedure

Plan human factors and usability engineering activities for medical device interfaces with this editable procedure. It guides teams in identifying intended users, use environments, critical tasks and use-related risks, then evaluating controls through the design process.

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Supplied as one editable Microsoft Word document in a digital download.

It focuses on the device user interface and all points of interaction with intended users, including displays, controls, packaging, labels and instructions for use.

Use-related risk analysis

The human factors and usability procedure identifies intended users, use environments and the device user interface before evaluating how a person may interact with the product. The team identifies critical tasks, known use problems and plausible use errors that could lead to harm.

Evaluation and controls

The procedure connects use-related hazards to design changes, information for safety and usability evaluation. It provides a way to record why a task is critical and how the design team will test or otherwise evaluate the effectiveness of the resulting controls.

The revised procedure references IEC 62366-1:2015 including Amendment 1:2020 for usability engineering and ISO 14971:2019 for risk management.

Apply these user-interface activities alongside the SaMD Development Procedure when the software itself is a medical device.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Usability and Customer Requirements Validation for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in Medical Device Software Procedure Bundle. Explore the bundle for the related documents.