Human Factors Engineering for Safe and Intuitive Products
Design safe, intuitive products by integrating human factors, risk management, and engineering to ensure usability, safety, and certification readiness.
Our Capabilities
Human Factors Engineering at Pilotfish spans the fulldevelopment lifecycle, from early user research to final validation andregulatory documentation.
We generate qualitative insights throughuser research and quantitative evidence through formative and summativeevaluations, integrating both with structured risk management and traceability to ensure every usability decision is justified, documented, and compliant.
Regulatory Documentation & Compliance Support
We build compliance into the process, not after it.
All activities are documented within a Usability Engineering File aligned with IEC 62366-1, MDR, and FDA guidelines. Deliverables are structured to integrate directly into your technical documentation, accelerating certification.
Formative Evaluations
We test early and iterate continuously with representative users.
Using a mixed methods approach, we combine observed user behaviour and feedback with measurable data such as task success, time on task, and error frequency to identify usability issues, safety concerns, and areas for improvement.
Use-Related Risk Assessment (URRA)
Use-Related Risk Assessment is integrated into our ISO 14971-based risk management process.
We identify safety-critical user interactions, classify hazards and potential harms, and define mitigation strategies from the start.
Establishing Use & User Interface Specifications
We define how the product will be used and how users will interact with it.
Through observational studies, contextual inquiry, task analysis, and user profiling, we document the use environment and identify potential use errors early.
These insights form the foundation for design, engineering, and risk management decisions.
Validation of User Needs
We define user needs basedon real use, not assumptions.
Through targeted research such as expert interviews, workflow mapping, and focused discussions we confirm that identified needs reflect actual conditions in practice.
This helps to set the right direction early, before design decisions introduce unnecessary cost and complexity.
Why choose us?
Fully integrated process under one roof
Hands-on expertise across hardware and software
Proven impact on product success
Certification-ready documentation
Reduce Risk. Improve Usability. Accelerate Certification.
Let’s integrate Human Factors Engineering into your product from day one.
Related projects
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What innovators often ask us?
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Through Use-Related Risk Assessment (URRA), integrated with ISO 14971 risk management, identifying hazard-related use scenarios and defining mitigation strategies early.
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Yes. Our Human Factors Engineering outputs are aligned with FDA and MDR requirements and can be directly integrated into your technical file.
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It is a structured set of documentation required for compliance, capturing all usability activities, findings, and risk mitigations.
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We embed it across all phases, from product definition, through conceptualization to engineering freeze and summative evaluation ensuring continuous verification & validation.
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Because usability directly impacts safety and compliance. This is why regulatory bodies, such as FDA and MDR, require structured usability engineering processes.
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It is the process of designing products based on how people actually use them. It ensures usability, safety, and effectiveness, especially in regulated environments like MedTech.