Human Factors Engineering

Use errors are among the leading causes of medical device adverse events. FDA and international regulators require manufacturers to systematically identify and mitigate use-related risks as part of the device design and development process.

IEC 62366-1:2015+AMD1:2020 and AAMI HE75:2009 form the core HFE framework for medical devices globally. FDA's 2016 HFE Guidance further specifies expectations for 510(k), De Novo, and PMA submissions.

Software Quality Guru's HFE team brings both regulatory expertise and applied human factors science — bridging the gap between compliant documentation and genuinely safer device interfaces.

The Use-Related Risk Analysis is the foundational HFE deliverable, identifying all use scenarios where user interface design could contribute to harm. It feeds directly into ISO 14971 risk management.

We develop your URRA by: defining intended user populations and use environments, creating comprehensive task analyses, identifying critical tasks where use error could cause or contribute to serious harm, and mapping user interface design elements to hazardous situations.

The URRA also drives the scope of your summative usability evaluation — a critical FDA expectation that many manufacturers underestimate.

Formative usability studies are conducted iteratively during design development to identify and fix use problems before they become expensive late-stage issues or regulatory findings.

We design and facilitate formative studies using: cognitive walkthroughs, think-aloud protocols, heuristic evaluations, and simulated use studies with representative users in simulated clinical environments.

Formative study findings are documented in a Formative Evaluation Report and fed back into the design process via your design controls — creating a defensible iteration history.

The summative (validation) usability test is typically the capstone HFE activity required for FDA submissions. It must demonstrate that representative users can safely and effectively use the final device design.

We manage the complete summative process: test protocol development, participant recruitment (representative users per FDA guidance), test facilitation, data analysis, and Summative Evaluation Report preparation.

Critical task pass/fail criteria, use error analysis, and near-miss documentation are all addressed in our summative reports to meet FDA reviewer expectations.