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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Design and Development Control SOP with 6 templates: Plan, I/O Matrix (Excel), Review Record, Verification, Validation, Transfer Checklist. Largest package in the kit.

Architecture and detailed design template per IEC 62304 §5.3 — item/unit decomposition, interfaces and SOUP integration. Editable Word template.

IEC 62304 Software Development Plan with safety classification, lifecycle activities and full regulatory mapping. Editable Word template.

IEC 62304 §5.2 Software Requirements Specification with risk-control flags, per-requirement safety class and traceability hooks. Editable Word template.
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