We plan and execute formative studies and summative usability validation and deliver submission-ready documentation for 510(k), De Novo, and PMA pathways for your human factors engineering process.
USE-Ing. helps your covering everything what the FDA expects from formative evaluations, critical task analysis, and summative usability validation—and how to translate findings into design changes and submission-ready evidence.
Sicherere Medizinprodukte entwickeln durch ein systematisches Usability-Engineering-Verfahren.
Wie man IEC 62366-1 erfolgreich anwendet: praktische Strategien zur Beschleunigung der Zulassung, Minimierung von Anwendungsfehlern und Erhöhung der Patientensicherheit.
Warum das wichtig ist
Beginnen Sie damit, Ihren Usability-Engineering-Prozess für Medizinprodukte zu stärken.
We support U.S. time zones, NDA workflows, and study documentation aligned with regulatory expectations.
Certified Medical Devices Usability Expert (TÜV)
UXQB® Certified Professional for Usability and User Experience (CPUX-F)
We investigate users, environments, workflows, and constraints that directly affect safe and effective device use. This includes contextual inquiry, interviews, and early formative evaluations depending on project maturity.
User groups, use environments, and key workflows
Task and workflow breakdown for realistic scenarios
Early design feedback for risk-relevant interaction points
We support teams in identifying hazards that arise from use, deriving critical tasks, and defining the conditions that must be addressed through interface design, labeling, training, and validation.
URRA inputs consolidated into a testable structure
Critical task list with rationale and traceability
Test scenarios that reflect real-world conditions and foreseeable use errors
We document intended users, environments, and use scenarios and translate them into UI requirements that can be verified and tested. This supports consistent decisions across design, risk management, and verification.
Use specification (users, environments, scenarios)UI requirements with measurable acceptance criteria
UI requirements with measurable acceptance criteria
We design and conduct summative usability validation to demonstrate that intended users can perform critical tasks safely and effectively under realistic conditions, with predefined success criteria and robust documentation.
Validation protocol and moderator guide
Data capture plan, deviation handling, and analysis structure
Summative validation reporting aligned with FDA expectations
Bring your current design stage, risk status, and submission timeline—we will propose a practical HFE plan.
Interactive online training for professionals focusing on the regulatory human factors and usability engineering process for medical devices.