Human Factors Engineering for Medical Devices helps teams design products that people can use safely, effectively, and with confidence. If you build medical devices for the EU, UK, China, Canada or US, human factors (also called usability engineering) is no longer “nice to have.” It’s required. In Switzerland and across Europe, regulators expect clear evidence that you identified critical tasks, tested with real users, and reduced use-related risk. In this guide, we’ll show you a practical, audit-ready path to compliance under IEC 62366-1 and EU MDR, plus what the FDA expects for submissions.
What Is Human Factors Engineering for Medical Devices?
Human factors is the science of how people interact with products, tasks, environments, and information. In medical devices, the goal is simple: reduce the chance of use error and improve safe, effective use. It covers everything from button layout and screen flow to labeling, training, and lighting where the device is used (hospital, clinic, home).
Why it matters for safety, usability, and risk reduction
When HFE is done well, users complete critical tasks correctly the first time. Complaints drop. Training time shrinks. Design teams focus on what actually prevents harm. Most importantly, your device demonstrates safety in normal use, a key expectation in standards and guidance.
Key definitions: use error, critical tasks, intended users & environments
Use error
An action or lack of action that could lead to harm.
Critical task
A step that, if done incorrectly or skipped, could cause serious injury or patient harm.
Intended users
The people who will use the device – clinicians, patients, or caregivers.
Use environments
Where and how it’s used: ICU, OR, GP clinic, ambulance or home.
IEC 62366-1 & MDR: The Compliance Backbone
IEC 62366-1 defines a usability engineering process for medical devices. It connects to your risk management so you can identify hazards tied to use and show how design changes reduce them. Under the EU MDR, notified bodies look for a clear Usability Engineering File (UEF) and evidence that you tested realistic use scenarios.
How IEC 62366-1 links to ISO 14971 risk management
Usability engineering feeds into risk control: user research → task analysis → hazards → mitigations → verification/validation. Your UEF should trace each hazard to specific design controls and test results. (The FDA also recognizes IEC 62366-1 as a consensus standard.)
EU MDR expectations and notified body evidence
Expect reviewers to ask: Did you identify critical tasks? Are samples representative of intended users? Did you simulate realistic conditions? Are results linked to residual risk? Your UEF should make this easy to see.
FDA Pathway: Human Factors for 510(k), De Novo & PMA
In the US, the FDA’s Applying Human Factors and Usability Engineering to Medical Devices (2016) outlines when and how to present HFE evidence. The FDA also issued guidance for combination products (2023) and a draft (2022) on what HFE information to include in marketing submissions. If critical tasks exist, expect to provide a Human Factors Validation study and a clear HFE report.
When FDA requires HFE/UE reports and validation studies
If use-related risks could lead to serious harm, plan for summative validation. The report typically includes user profiles, task analyses, risk-based rationales, protocol, acceptance criteria, results, and residual risk justifications.
Laws and Regulations | Standards | Best Practices |
|---|---|---|
MDR Medical Device Regulation | IEC 62366-1:2015 + COR1:2016 + A1:2020 Application of usability engineering to medical devices | IEC/TR 62366-2:2016 Guidance on the application of usability engineering to medical devices |
IVDR In vitro Diagnostic Medical Device Regulation | ISO 14971:2019 Application of risk management to medical devices | EN 301 549 V3.2.1 Accessibility requirements for ICT products and services |
DiGAV Digital Health Applications Ordinance | ISO 13485:2016 Quality management systems and requirements for regulatory purposes | ISO 9241 (Parts 110, 112, 125) Ergonomics of human-system interaction – interaction and information design principles |
FDA 21 CFR part 820 Quality System Regulation | FDA Guidance Document "Applying Human Factors and Usability Engineering to Medical Devices" |
Human Factors and Usability Laws, Regulations and Standards in MedTech
This section outlines the legal, regulatory, and normative frameworks relevant to Human Factors and Usability Engineering in Switzerland, the European Union, and the United States.
It focuses on the frameworks that directly influence your development activities in MedTech, including medical devices, IVDs, and digital health products.
Laws and Regulations
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IVDR
In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
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MDR
Medical Devices Regulation (EU) 2017/745
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FDA 21 CFR Part 820
Quality System Regulation (QSR)
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DiGAV
Digital Health Applications Ordinance (Germany)
Standards
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IEC 62366-1:2015 + COR1:2016 + A1:2020
Application of usability engineering to medical devices
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FDA Guidance Document
Applying Human Factors and Usability Engineering to Medical Devices
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ISO 14971:2019
Application of risk management to medical devices
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ISO 13485:2016
Quality management systems – Requirements for regulatory purposes
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IEC 60601-1-6
Usability engineering for medical electrical equipment
Best Practices
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IEC/TR 62366-2:2016
Guidance on the application of usability engineering to medical devices
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EN 301 549 V3.2.1
Accessibility requirements for ICT products and services
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ISO 9241 (Parts 110, 112, 125)
Ergonomics of human-system interaction – interaction and information design principles
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ISO 9241-210:2019
Human-centred design for interactive systems
The HFE Process: From Research to Validation
User research & context of use (ethnography, interviews, heuristic reviews)
Start with real users in real contexts. Observe tasks, lighting, noise, PPE constraints, and time pressure. Map workflows and create use error hypotheses. Heuristic reviews and cognitive walkthroughs quickly reveal interface friction.
Formative studies: prototypes, task analyses, use-related risk controls
Run small, iterative tests. Explore labels, on-device affordances, and training materials. Build a task inventory, mark critical tasks, and apply controls (design changes before instructions). Keep testing until error rates drop and usability improves.
Summative (validation) testing: protocol design, sample size & success criteria
Design a statistically sound protocol. Recruit representative users by role and experience, simulate stressors (alarms, gloves), and pre-define acceptance criteria for each critical task. Collect both objective metrics and root-cause observations. Align reporting to IEC 62366-1 and FDA expectations.
Documentation That Passes Audits
Usability Engineering File (UEF): contents & traceability
Include: user profiles, context of use, hazards/risks, task analyses, formative findings, design decisions, summative protocol & results, and residual risk rationale. Use a traceability matrix linking hazards → controls → evidence.
Design history & evidence mapping to hazards and mitigations
Keep minutes and design logs. Capture trade-offs and risk-benefit reasoning. Show that labeling or training is never the first control if a design change can prevent the error.
Special Cases: SaMD, DTx, Combination Products & Home Use
Digital health interfaces & cognitive workload
For apps and connected devices, focus on navigation clarity, alarm fatigue, and data legibility across screens. Test with real-world interruptions and accessibility needs.
Combination products: injection devices, IFUs & training decay
For autoinjectors and inhalers, pay extra attention to training retention over time and the clarity of IFUs. Align to FDA’s combination product guidance.
How HUMAN FACTOR LAB Works With You
Explore our full range of services across the entire usability engineering process. Whether you need targeted support in a specific phase or guidance throughout the full development cycle – our services adapt to your needs. Learn more about each offering and find the right support for your project.
Risk & gap review of your current design.
Formative testing loops with quick iterations.
Summative validation with audit-ready reporting.
Regulatory narrative mapping evidence to IEC 62366-1, MDR and FDA expectations.
Free Expert Consultation
(30 Minutes)
A focused discussion with a HF Expert to define the right HFE path.
Starter HFE Audit
(2 weeks)
Risk & task review, UEF outline, formative test plan.
Formative Sprint
(4–6 weeks)
Recruit, moderate, analyze, iterate, and re-test.
Summative Study
(6–10 weeks)
Protocol, recruitment, dry-runs, execution, analysis, and HFE report.
