
Vulnerability Disclosure Policy
€69.00
SKU
CYB-03
Category Medical Device Cybersecurity
Tags Cybersecurity, IEC 81001-5-1, Vulnerability Disclosure
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
A coordinated Vulnerability Disclosure Policy defining in-scope and out-of-scope systems, the reporting channel and urgent-safety escalation path, safe-harbour provisions for security researchers, and the assessment-to-disclosure timeline. It supports IEC 81001-5-1 and FDA postmarket cybersecurity expectations. Fully editable Word template.
€69.00
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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.

