Strategy & planning
Right-size human factors activities across a product pipeline, from feasibility research through post-launch monitoring—and shape your strategy for implementing the right AI in your products.
Safer use. Stronger submissions.
Design out use risks
Human factors and usability engineering for medical devices, drug delivery systems, and AI-enabled products—from early research through FDA/EMA-ready validation.
Medical devicesDrug deliveryAI-enabled products
What we do
Support across the product lifecycle.
From a focused expert review to a complete human factors program, each engagement is shaped around your product, development stage, team, and regulatory path.
Use-related risk analysis
Analyze user tasks and foreseeable use errors, then connect findings to design, labeling, and training mitigations.
Formative & summative studies
Plan and run iterative formative research and validation studies that support confident design decisions and regulatory submissions.
Heuristic reviews
Evaluate concepts and prototypes early to uncover usability issues before they become expensive to change.
User & usability research
Turn contextual inquiry, interviews, surveys, personas, and user journeys into actionable product and technical requirements.
Teams, systems & data
Build in-house capability with hiring, procedures, templates, contract support, and biometric, anthropometric, and behavioral data collection.
Why act early
Find use errors before validation.
Late-stage use issues can force costly changes to the product, labeling, training, or submission plan. A deliberate human factors program brings those issues forward—when there is still time to resolve them.
Review your programUnderstand the real context
Study users, environments, workflows, and the conditions that shape safe use.
Connect evidence to risk
Translate observed behavior into clear priorities for product and program decisions.
Iterate with purpose
Test changes, resolve critical issues, and build a coherent evidence trail toward validation.
Where we focus
Complex products. Human realities.
Technical sophistication only creates value when people can use it safely and effectively. SEIFION connects product design, user evidence, risk, and regulatory expectations.
Regulated products
Human factors programs for medical devices and drug-device combination products, aligned to FDA and EMA expectations.
Critical interactions
Research and analysis that expose where interfaces, instructions, training, and real-world behavior can break down.
The right AI, by design
We help teams decide where AI belongs in their product—and where it doesn't. Strategy and UX research that turns AI features into interfaces people can understand, trust, and use safely, with validation evidence ready for FDA/EMA review.
Common questions
Medical device human factors, explained.
Clear answers to questions teams ask when planning usability engineering and regulatory evidence.
When should human factors engineering begin in medical device development?
Human factors work is most useful when it begins early, while user needs, interface concepts, labeling, and risk controls can still influence the design. Early research and iterative formative evaluations can expose use-related risks before validation.
What are formative studies?
Formative studies are iterative evaluations conducted during development to identify use difficulties, understand their causes, and guide improvements. They can use early concepts, prototypes, labeling, or training materials, and their findings inform the user interface and use-related risk analysis.
What are summative studies?
Summative studies are formal evaluations of the final or production-equivalent user interface with representative intended users and use conditions. They focus on critical tasks and provide evidence that the interface can be used safely and effectively; in an FDA human factors program, this is commonly called human factors validation testing.
What is verification testing?
Verification testing provides objective evidence that design outputs meet specified design inputs and requirements. It may confirm dimensions, performance, software behavior, or other specifications; unlike validation, it asks whether the product was built according to its requirements.
What are validation studies?
Validation studies provide evidence that the finished device meets user needs and intended uses under actual or simulated use conditions. Human factors validation is one part of this evidence, focused on whether intended users can perform critical tasks safely and effectively.
What are FDA's human factors submission categories for medical devices?
Under FDA's final guidance Content of Human Factors Information in Medical Device Marketing Submissions (effective August 1, 2026), every 510(k), De Novo, PMA, and HDE is sorted into one of three categories based on critical tasks — tasks that could cause or contribute to serious harm if performed incorrectly or not at all. Category 1 covers modifications that don't affect human factors considerations; Category 2 covers devices with no critical tasks, or where a documented rationale supports not submitting validation testing; Category 3 requires full summative validation data. The category you claim determines how much human factors evidence travels with your submission.
When can we justify skipping summative validation testing?
The guidance adds a Decision Point D to the category flowchart, weighing three factors: the history of safe use or known use errors for the interface, whether the interface is complex, and whether existing risk controls remain adequate with no new risk information. When those factors support it — for example, FDA cites a low-complexity device similar to long-marketed predicates — you can land in Category 2 with a documented rationale instead of new summative testing. A complex interface or a history of known use errors points the other way, toward Category 3.
Can a labeling change (such as changes to the IFU or the device label) affect the FDA submission?
Yes. At Decision Point B, FDA assesses labeling changes alongside changes to the user interface, users, uses, and use environments — so a labeling change means you can't stay in Category 1 and must assess critical tasks at Decision Points C and D, which can land the submission in Category 3. For modified devices, FDA also expects the analysis to cover tasks upstream and downstream of the change — not just the changed task. Getting the category wrong risks Additional Information requests and repeating the validation work.
How does IEC 62366-1 relate to an FDA human factors program?
IEC 62366-1 describes a usability engineering process for identifying, evaluating, and controlling use-related risks. FDA human factors expectations similarly emphasize intended users, use environments, critical tasks, risk analysis, formative evaluation, and validation evidence.
Does SEIFION support combination products and AI-enabled products?
Yes. SEIFION supports medical devices, drug-device combination products, drug delivery systems, and AI-enabled products, from early research and strategy through validation-ready evidence.