Alessandra Santangelo

I'm currently supporting Capsula's digital health products through regulatory, quality, compliance, clinical, and product-development workstreams. I prepare structured documentation for software-based medical devices, including classification, intended-use alignment, technical documentation, and evidence planning.

I've led ISO 13485 surveillance preparation and supported an ISO 27001 compliance roadmap from gap assessment through documentation, improving audit readiness and traceability. I also contribute to digital diagnostics, AI-enabled workflows, feasibility assessments, clinical study planning, protocol development, and scientific documentation.

Before Capsula, I worked at EY Advisory on PONGOV-Chronicity and healthcare transformation initiatives involving telemedicine, clinical governance, and digital health. My work combined project design, stakeholder engagement, analysis, documentation, reporting, and solution development for chronic-care implementation.

My foundation is in translational oncology and clinical research, including liquid biopsy and biomarker discovery at the University Hospital of Verona. I've contributed to six peer-reviewed publications and bring experience in medical statistics, evidence synthesis, systematic reviews, molecular biology, and scientific communication.