MedTech

Human factors engineering for medical devices, SaMD, IFU and labeling, and the critical tasks that shape safe use.

Research shaped by the work.

Plan usability engineering around the intended users, use environments, and critical tasks. Formative evaluation informs design and use-risk controls before design freeze; summative validation evaluates the final design with representative users.

FDA Human Factors Guidance
IEC 62366-1
ISO 14971
AAMI HE75

Protocols, residual use-risk analysis, and HFE/UE reporting support the applicable FDA submission pathway. Human factors validation supports overall device design validation; it does not guarantee clearance or replace other required evidence.

Focused packages.

UI Safety Review

Scope: An agreed interface, its critical tasks, and available design and risk documentation.
Timeline: Agreed after interface and risk review

Included services

Heuristic Evaluation
Cognitive Walkthroughs
Use-Related Risk Assessment

Deliverables

Prioritized usability and use-risk observations
Critical-task and interface recommendations
Review findings and design priorities

View package

Formative Evaluation

Scope: A defined prototype or device, representative user groups, and agreed tasks and study conditions.
Timeline: Agreed around recruitment and prototype readiness

Included services

Usability Testing
Formative Studies
Simulation & Workload Evaluation

Deliverables

Study protocol and observed task findings
Use errors, root causes, and design recommendations
Priorities for refinement and retesting

View package

Summative Validation Support

Scope: An agreed MedTech validation milestone, final design, critical tasks, user groups, and applicable pathway.
Timeline: Agreed around design readiness and recruitment