Cybersecurity Risk Assessment & Threat Model
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
A medical device cybersecurity risk assessment and threat model aligned to IEC 81001-5-1 §5.4 and the FDA 2023 Cybersecurity guidance. It provides a complete scoring methodology — STRIDE threat identification, DREAD-based likelihood adapted from NIST SP 800-30r1 and AAMI TIR57, and CIA-triad impact — together with system characterisation, asset and threat registers, and risk determination with acceptability criteria. Fully editable Word template, roughly 75–80% deliverable.
€69.00
Alessandro Stella
Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.