AI Development & Lifecycle Plan (AI-01)
€69.00Master AI/ML lifecycle plan integrating IEC 62304, the IMDRF GMLP principles and the Health Canada 9-stage ML lifecycle.
Showing all 11 results
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Design and Development Control — Process Package (ISO 13485)
€69.00Design and Development Control SOP with 6 templates: Plan, I/O Matrix (Excel), Review Record, Verification, Validation, Transfer Checklist. Largest package in the kit.
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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 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.
