Usability - Qity

Usability Engineering

MDR, FDA and MHRA demand that medical devices are guarded against unintentional misuse.

Qity provides expert consultation on the entire process of designing, developing, and testing medical device user interfaces, in compliance with IEC 62366-1, Application of usability engineering to medical devices, MHRA and FDA Guidelines.
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Portfolio

Compliance assessment
Compliance assessment to ensure processes, Technical File, Usability Engineering File and plans meet the requirements of IEC-62366-1, MHRA and FDA guidelines.
Usability Engineering Process
Establish a usability engineering process, workflow and tools, in compliance with IEC-62366-1, MHRA and FDA guidelines.
User Research
Identification of stakeholders, stakeholder needs, impairments, and use environment.
User Interface Design & Development
User experience design, prototyping, pixel-perfect user interface design, and software implementation.
Use-Related Risk Analysis
Identification of hazard-related use scenarios, task and function analysis, PCA-analysis (Perception, Cognition, Action) and risk mitigation strategies.
Expert Review
Expert reviews are an easy way of performing formative usability evaluation. Qity's usability experts will easily spot common user interface flaws.
User Interface Evaluation
Creation of Usability Evaluation Plan, Usability Test Protocols, and execution of Usability Tests.