Use-Related Risk
We check whether hazards, use errors, mitigations, labeling, and training controls are traceable to the device interface.
Usability Engineering
Build usability evidence before interface risk becomes a review issue.
Usability evidence fails when it is treated as a final report.
Critical Task Evidence
We review whether critical tasks are defined, justified, and supported by the right formative or validation evidence.
Validation Readiness
We identify gaps in user groups, scenarios, protocols, reports, and usability engineering file structure before formal review.
Service specification
Korea Usability Engineering
The service defines what we review, what you provide, what you receive, and which study execution or remediation work sits outside the base scope.
Request assessmentFor Korea, we map usability evidence to MFDS expectations, IEC 62366-1 logic, SaMD or AI interface considerations, and Korean technical documentation needs.
Use-related risk, user groups, use environments, critical tasks, formative evidence, validation strategy, and UEF structure.; Participant recruitment, full study execution, facility management, and report authoring unless separately scoped.
Usability evidence gap matrix with priority, rationale, and recommended action.; Working session to align regulatory, design, clinical, and usability owners.
Typically 2-4 weeks after complete intake.; Kickoff, document intake, evidence review, gap report, and review meeting.
Intended use, user profiles, interface description, risk file, task analysis, formative records, protocols, and reports.; Access to product, clinical, regulatory, and design owners for clarifications.
One consolidated feedback round on the report after delivery.; Email or shared workspace for decisions and document control.
Fixed fee when file scope and inputs are clear.; Study design, recruitment, test execution, authoring, and submission work are scoped separately.
Frequently Asked Questions
Common questions about medical device usability engineering.