Use specification
Intended users, patient groups, use environments, operating principle, user profiles, training assumptions and foreseeable use conditions.
Human Factors & Usability
Human factors and usability support for medical devices.
We support proportionate usability engineering for SaMD and software-enabled devices, from use specification and risk analysis through study planning, documentation and regulatory integration.
Selected clients
Healthcare teams we have supported
Scope and deliverables
Usability engineering work included in the service.
Capability is defined by the agreed project team. Where independent moderators, representative-user recruitment, specialized facilities or additional human-factors expertise are needed, those roles are identified rather than implied.
Task and interface analysis
User workflows, task decomposition, interface boundaries, information flow and identification of tasks with potential safety consequences.
Use-related risk analysis
Use errors, close calls, foreseeable misuse, hazardous scenarios, critical tasks and links to ISO 14971 risk controls.
Formative evaluation planning
Learning objectives, participant profiles, scenarios, moderation approach, observations and iterative design feedback.
Validation strategy and protocol inputs
Representative-user groups, critical-task scenarios, training decay, acceptance rationale, data capture and analysis planning.
Regulatory documentation
Usability engineering file structure, FDA submission narrative or EU technical-documentation inputs, findings and residual-risk rationale.
Ways to work together
Choose the support your team needs.
Usability file gap review
Assess existing design and risk records against the pathway and identify the work still needed.
Planning and documentation
Develop use specification, analyses, protocols and reports with agreed specialist and sponsor inputs.
Submission response support
Trace an authority question to the underlying design, study or documentation gap and structure the response.
How it works
Our process.
- 1
Understand use
Define users, tasks, environments, training, interfaces and safety context.
- 2
Analyze risk
Identify critical tasks and connect use errors to hazardous situations and controls.
- 3
Evaluate
Plan proportionate formative and, where required, validation work with qualified roles.
- 4
Document
Consolidate methods, results, design actions, residual risk and submission evidence.
Regulations, standards and guidance considered
IEC 62366-1IEC/TR 62366-2ISO 14971FDA Human Factors GuidanceFDA Human Factors Content GuidanceANSI/AAMI HE75EU MDR Annex IIEC 62304
Frequently asked questions
Questions teams ask before they begin.
Is usability the same as user experience design?+
No. User experience can address satisfaction and convenience; regulatory usability engineering focuses on safety-related interface characteristics, foreseeable use errors and evidence that risk controls support safe and effective use.
When is human-factors validation needed for FDA?+
FDA expects the need and scope to follow from use-related risk. Validation is generally important when critical tasks remain and the user interface is relied on to control serious use-related harm. Product-specific FDA guidance and feedback may alter expectations.
How many participants are required?+
There is no universal number for every study. FDA often discusses at least 15 participants per distinct user population for many validation studies, but the correct design depends on user groups, risk, device, tasks and current guidance. A number alone does not make a study adequate.
Can employees act as representative users?+
Usually not for validation if their product knowledge, training or professional background differs from intended users. Representativeness should cover relevant characteristics, experience and use conditions, with exclusions justified.
Does Predetics provide recruitment and a usability lab?+
Those capabilities are not assumed. We define the required participant, moderation and environment specifications and agree whether the sponsor or qualified external providers will supply recruitment, facilities or independent specialist services.
Can human-factors acceptance be guaranteed?+
No. Authorities assess whether methods, representativeness, critical-task coverage and conclusions are adequate. Early planning and traceability reduce avoidable gaps but do not guarantee a decision.
Start with the product you have