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
Key Responsibilities
Led the end-to-end UX/UI process for Nelli®, aligning user needs, design decisions, and usability evidence to support MDR compliance and FDA 510(k) clearance.
Planned and conducted formative and summative usability tests, identifying safety-critical issues and validating compliance with regulatory usability requirements.
Applied IEC 62366 and ISO 14971 standards to improve usability documentation quality, risk traceability, and audit readiness.
Identified and documented 300+ usability risks, using them to guide design refinements that reduced potential use errors and improved clinical workflow safety.
Designed the full web application UI, enabling more efficient clinical event review through iterative, evidence-based design updates.
Created 10+ personas, workflows, and prototypes to align clinical, technical, and user needs, improving development clarity and stakeholder alignment.
Authored usability engineering documentation (protocols, scripts, reports) used directly in MDR audits and FDA submissions.
Defined the company’s Human Factors Engineering SOP, standardizing usability processes and strengthening compliance consistency across development.
Collaborated with engineers, data scientists, clinicians, QA, and RA to ensure UI designs were feasible, clinically accurate, and aligned with regulatory expectations.
Supported external audits, contributing to a stronger regulatory posture.
Contributed to product roadmap and feature prioritization, ensuring user needs and risk controls informed development decisions.
Led a small development team, improving coordination, communication, and consistency in feature delivery.








