Vulnerability Disclosure Policy
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
What it is: a professionally drafted Word template for a Coordinated Vulnerability Disclosure (CVD) policy, as expected by IEC 81001-5-1 and MDCG 2019-16 and modeled on ISO/IEC 29147. The policy establishes how security researchers and users can report vulnerabilities, and how the manufacturer triages, remediates, and communicates them.
What is included
- Scope of products and versions covered
- Reporting channels and secure communication methods
- Triage, severity scoring (CVSS), and remediation timelines
- Safe harbor statement for good-faith researchers
- Communication to users, distributors, and competent authorities
- Interface with vigilance and post-market surveillance processes
- References to ISO/IEC 29147 and ISO/IEC 30111
Format
1 Microsoft Word .docx file (fully editable) + slim README with usage instructions. Delivered as a small ZIP. Instant download after purchase.
Need the full lifecycle?
This is 1 of 12 templates in the IEC 62304 & Cybersecurity Documentation Kit.
€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.