WORKFLOW AND TASK ANALYSIS
Have you pinned down the ideal use case?
One of the first steps in the HF process is to clearly define the current state workflow and analyze each task to identify challenges, inefficiencies, and potential risks.
HEURISTIC ANALYSIS
Need a baseline check on usability?
Our human factors experts provide usability assessments through hands-on prototype or production unit reviews. This process identifies risk areas to be addressed through design and HF studies.
ERGONOMIC MOCK-UPS
Want options on use cases and ergonomics?
Our human factors and industrial design team members create mock-ups to simulate device use. These mock-ups are often used in formative HF studies to gain early user feedback.
FORMATIVE HUMAN FACTORS STUDIES
Seeking user feedback to guide design decisions?
Our human factors experts capture early feedback on device designs to guide concept down-selection and identification of user related risks.
IFU DEVELOPMENT
Need clear IFUs for your combo product?
Our human factors team members will help you create clear and comprehensive IFUs, quick start guides, and training materials to guide safe and effective combo product use.
USER RELATED RISK ANALYSIS (URRA)
Aiming to flag usability risks early?
Our HF team members will help youidentify hazards, assess potential harms, and analyze risks related to user misinterpretations and errors. Our human factors process and documentation is completed in compliance with IEC 62366.
SUMMATIVE HUMAN FACTORS STUDIES
Need to confirm that usability risks are mitigated?
Our HF team will help you conduct summative HF studies to evaluate any residual risks as part of the validation process. All HF protocols and reports are formatted to report regulatory submissions.
THRESHOLD ANALYSES
Want support for generic combination products?
Our HF team will help you conduct threshold analyses to compare your device and its use with the reference listed device (RLD) while developing documentation to support your ANDA.
LET'S CONNECT
Looking for Human Factors Support?
Contact us through the form below. One of our team leaders will follow-up with you directly.