CORE ServiceS
04. Human Factors & Design Validation
Safety is a science, not a checkbox. We accompany your development process & prove your product is safe and effective through rigorous, audit-ready design validation that withstands global scrutiny.
ENSURE SAFETY. SECURE APPROVAL.
“We translate complex use risks into rigorous controls and validated evidence.”
KEY OUTPUTS & DELIVERABLES
Human Factors Program Planning & Execution
A comprehensive roadmap defining all HFE activities, participant groups, and IEC 62366-1 compliance milestones - expertly executed.
User Interface Evaluation Planning
Strategic definition of formative and summative methodologies, including regional testing requirements.
UOUP Process for Legacy Devices
Specialized gap analysis and "User Interface of Unknown Provenance" processing to bring legacy products into modern compliance.
Threshold Analysis
Strategic assessments to determine potential validation waivers for generic or modified combination products.
04.a
HFE Regulatory Strategy & Execution
Define the winning pathway and establish the technical framework.
One size does not fit all. We analyze your product complexity and predicate history to define the most efficient design validation strategy. By determining critical tasks and participant grouping early, we satisfy FDA/MDR expectations and provide a clear roadmap that avoids the cost of over-testing. If you like, we take on all HFE-related tasks in your project and create audit-ready documentation.
KEY OUTPUTS & DELIVERABLES
Use Specification & UI Characteristics
Audit-ready record of intended users, environments, and safety-related user interface characteristics.
PCA & Hierarchical Task Analysis (HTA)
Deep-dive breakdown of user steps to identify primary operating functions, potential use errors, and critical tasks.
Known Use Problems (KUPA)
A benchmark analysis of safety issues and recalls from similar marketed devices to ensure "historical" risks are addressed in your new design.
Hazard & Situation Identification
Systematic mapping of known use problems (KUPA) and foreseeable hazardous situations related to the interface.
Use-Related Risk Inputs (uFMEA)
Direct translation of task analysis findings into hazard-related use scenarios and risk-control requirements.
04.b
Task Analysis & Use Specification
Decompose the workflow to identify risk before you build.
You cannot validate what you have not defined. We break down user interactions into granular steps using PCA Analysis (Perception Cognition Action) to pinpoint failure modes. This establishes the basis for Risk Management and the identification of safety-critical characteristics.
KEY OUTPUTS & DELIVERABLES
Expert Review & Heuristic Analysis
Cognitive walkthroughs to facilitate rapid improvements before investing in human subject testing.
Simulated Use Discovery
Exploratory user testing to verify risk mitigations and select Hazard-Related Use Scenarios for summative validation.
User Interface Specification
A detailed technical document derived from iterative testing that defines the finalized design of the user interface.
Design Recommendation Logs
Actionable guidance and traceability documentation captured to justify design decisions before design freeze.
Systematic Risk Management
Precise specification and evaluation of risk-control measures to ensure use-related safety and compliance with ISO 14971.
04.c
Formative Evaluation & UI Specification
Iterate and optimize through evidence-based engineering.
This is where safety and usability is established. We conduct iterative testing loops to uncover use errors and finalize the User Interface Specification. These "fail-fast" cycles ensure that every element - hardware, software, packaging, and training - is optimized before the design is locked.
The study results were extremely valuable and Ergonomics Factory ensured that the study was completed within time and budget.
Alberto, Head of R&D, Italian Pharma Company.
KEY OUTPUTS & DELIVERABLES
Summative Validation Testing
Evaluation of production-equivalent products against selected high-risk Hazard-Related Use Scenarios.
High-Fidelity Simulation
Testing under representative clinical conditions (e.g., noise, lighting, stress) to mirror real-world use.
Ethical Approval & IRB
End-to-end management of IRB and Ethics Committee (EC) submissions for global human subject research.
Global Execution
Multi-regional testing conducted in all required languages with native-speaking moderators.
04.d
Summative Human Factors Validation
The definitive proof of use-related safety and effectiveness.
We execute the pivotal, GLP-compliant human factors validation study required for regulatory submission. By simulating realistic use environments - including clinical stress and potential training decay - we provide the formal evidence that your product is safe for commercial release.
Discover how rigorous validation transformed a complex regulatory challenge into commercial success.
Explore the case study ➔
KEY OUTPUTS & DELIVERABLES
Comparative Differentiation Studies
Specialized protocolized studies to prove users can distinguish between yours and other products or strengths.
Commercial Evidence
Hard data comparing performance against market incumbents to support clinical adoption and marketing.
Differentiation Risk Reports
Formal datasets that demonstrate successful risk mitigation of medication mix-ups and potential labeling-related recalls.
Threshold Analysis
Quantifiable analysis to support "Comparative Use Human Factors Studies" for abbreviated regulatory pathways.
04.e
Differentiation & Comparative Testing
Behaviorally prove superiority and prevent medication errors.
For combination products, distinguishing between variants is a critical safety requirement. We conduct specialized testing to prove users can clearly differentiate between dosage strengths via color, labeling, and tactile cues, satisfying regulatory equivalence and supporting commercial claims.
KEY OUTPUTS & DELIVERABLES
IFU Comprehension Testing
Formal, protocol-driven testing to ensure users can perform critical tasks safely using only provided materials.
Legibility & Readability Audits
Verification that safety icons, font sizes, and warnings meet international standards and are interpreted correctly.
Instructional Logic Mapping
A diagnostic of the user’s "onboarding" journey to simplify complex steps through visual and tactile cues.
Linguistic Validation
Confirmation that translated materials and localized icons maintain safety-critical clarity in global markets.
04.f
Legibility, Readability, and Comprehension Studies
Ensure safety-critical information is understood at a glance.
Instructions are not just "support material" - they are essential for safety. We conduct formal studies to validate that labeling, packaging, and Instructions for Use (IFU) effectively guide users. This ensures and demonstrates that safety-critical information is understood across all intended global markets.
KEY OUTPUTS & DELIVERABLES
Usability Engineering File (UEF)
The complete, integrated technical record required for audit as per IEC 62366-1.
HF/UE Summary Report
A regulatory-ready narrative of the product’s use-related safety profile and final residual risk conclusions.
User Needs Traceability Matrix
Final documentation linking every user need and requirement to a successfully validated outcome.
Regulatory Liaison
Strategic support for Q-Submissions and formal responses to regulatory deficiency letters.
04.g
HF/UE Report Authoring
The final submission argument for regulatory approval.
Data is only as strong as the narrative. We synthesize your entire journey into a Usability Engineering File (UEF) and a coherent safety argument. We ensure your technical record is bulletproof and ready for audit by FDA, Notified Bodies, or NMPA.
Thanks to Ergonomics Factory, we’ve quickly and effectively completed the design & development of our device.
Christoph, Senior Design Manager
Leading OEM Device Company.
The Strategic Outcome
Your Definitive Proof of Safety & Market Readiness.
The Human Factors & Design Validation services transform your design into a cleared medical technology. By delivering a complete Usability Engineering File (UEF) and behaviorally proving safety through GLP-compliant validation, we clear the final hurdle for global launch.
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Exploring Core Phase