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 14 results
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Cybersecurity Risk Assessment & Threat Model
€69.00Security risk assessment and threat model using STRIDE + DREAD + CIA, aligned to IEC 81001-5-1 and the FDA 2023 cybersecurity guidance.
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Problem Resolution & Anomaly Log (IEC 62304)
€69.00Anomaly and problem-resolution log per IEC 62304 §9 — severity, safety impact, root cause and an auto-calculated summary dashboard.
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Software Architecture & Detailed Design (IEC 62304)
€69.00Architecture and detailed design template per IEC 62304 §5.3 — item/unit decomposition, interfaces and SOUP integration. Editable Word template.
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Software Development Plan (IEC 62304)
€69.00IEC 62304 Software Development Plan with safety classification, lifecycle activities and full regulatory mapping. Editable Word template.
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Software Documentation Bundle Kit
€499.00What 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…
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Software Release & Configuration Management Record (IEC 62304)
€69.00Per-release configuration and release record per IEC 62304 §5.8 & §8 — semantic versioning, locked baseline and release-gate checklist.
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Software Requirements Specification (IEC 62304)
€69.00IEC 62304 §5.2 Software Requirements Specification with risk-control flags, per-requirement safety class and traceability hooks. Editable Word template.
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Software Traceability Matrix (IEC 62304)
€69.00Active Excel traceability matrix linking requirements, architecture, tests, risk controls and anomalies, with auto-calculated coverage summary.
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Software Verification & Validation Plan (IEC 62304)
€69.00V&V Plan per IEC 62304 §5.5–§5.7 with a structured test-case register (unit, integration, system, security) and defined release criteria.
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Software Verification & Validation Report (IEC 62304)
€69.00V&V Report capturing test execution, security/vulnerability-scan results, SOUP verification, deviations and the signed V&V conclusion.
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SOUP List & Evaluation Record (IEC 62304)
€69.00SOUP register and evaluation record per IEC 62304 §8, with CVE screening, safety classification and re-evaluation history. Active Excel workbook.
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SW Documentation Kit Gold
€799.00What it is: the complete software file for AI/ML-enabled medical devices and SaMD, in one coordinated set. Twenty-three professionally drafted templates across three modules — the full IEC 62304 software lifecycle, the complete AI/ML documentation set built on the IMDRF Good Machine Learning Practice principles, and the cybersecurity file expected under Regulation (EU) 2017/745. Everything…
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Vulnerability Disclosure Policy
€69.00Coordinated vulnerability disclosure policy — scope, safe-harbour, reporting channel and assessment-to-disclosure timelines.
