Cybersecurity Management Plan
€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 the Cybersecurity Management Plan expected under Regulation (EU) 2017/745, Annex I GSPRs 17.2 and 17.4, and aligned with MDCG 2019-16 and IEC 81001-5-1. The plan defines how security is managed across the entire software lifecycle, from secure development to post-market monitoring.
What is included
- Security risk management process linked to ISO 14971
- Threat modeling methodology and asset/interface inventory
- Security requirements definition and secure coding practices
- Secure development lifecycle activities per IEC 81001-5-1
- Post-market cybersecurity monitoring and vulnerability handling
- Security incident response and patch management process
- References to MDCG 2019-16 and FDA premarket cybersecurity guidance
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
Related products
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.