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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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 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.
