Cybersecurity Management Plan
€69.00Lifecycle cybersecurity management plan per IEC 81001-5-1 §5.6–§5.7 — vulnerability monitoring, CVSS triage and security patch management.
Showing all 4 results

Lifecycle cybersecurity management plan per IEC 81001-5-1 §5.6–§5.7 — vulnerability monitoring, CVSS triage and security patch management.

Security risk assessment and threat model using STRIDE + DREAD + CIA, aligned to IEC 81001-5-1 and the FDA 2023 cybersecurity guidance.

What it is: the complete IEC 62304 software lifecycle file plus the cybersecurity documentation expected under Regulation (EU) 2017/745, in one coordinated set. Twelve professionally drafted templates covering software development, verification, maintenance, and security — the full documentation package Notified Bodies expect for medical device software (safety Class A, B, or C) and SaMD. What…

Coordinated vulnerability disclosure policy — scope, safe-harbour, reporting channel and assessment-to-disclosure timelines.
MD Regulatory Insights
Stay ahead of the regulatory landscape
Leave your email and stay updated on EU MDR, IVDR, ISO 13485, MDSAP and global market access — plus what it means in practice for your technical documentation.
You're in.
Check your inbox to confirm your subscription — it should arrive within a minute. If you don't see it, have a look in the spam folder.
Added to cart
Check out our shop to see what's available