Nelli
Web application
Nelli is a certified web-based Class IIa medical device with FDA clearance for seizure detection and characterization, enabling video and audio recordings of events to support faster diagnosis, treatment decisions, and clinical follow-up.

Role
Lead UX/UI Designer
Responsibility
Ownership of UX
Regulatory & Safety Impact
Supported MDR compliance and FDA 510(k) clearance by leading the UX and Human Factors process and usability documentation for submissions and audits.
Built a structured usability risk and traceability framework by applying IEC 62366 and ISO 14971 and documenting 300+ hazard-related use risks to guide design decisions.
Validated regulatory usability requirements and translated safety-critical findings into design controls through formative and summative testing in clinical environments.
Product & Workflow Impact
Improved clinical event review workflows through iterative, evidence-based UI design in close collaboration with engineering, clinical, and regulatory stakeholders.
Ensured clinically accurate and technically feasible UI solutions through continuous collaboration with engineering, data science, QA, RA, and clinicians.
Contributed user and risk perspectives to feature prioritization discussions with the development team.
Research & Alignment Foundations
Established a shared understanding of clinical user needs by developing personas and workflows during foundational user research.
Bridged research, development, and end-user adoption by writing user stories and epics, facilitating feedback sessions, and supporting user training.
Organizational Contribution
Standardized Human Factors practices across the organization by defining and implementing the Human Factors Engineering SOP and work instructions.
Improved coordination by leading a small development team.







