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 12 results
-
-
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.
-
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.
-
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.
-
Software Development Plan (IEC 62304)
€69.00IEC 62304 Software Development Plan with safety classification, lifecycle activities and full regulatory mapping. Editable Word template.
-
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…
-
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.
-
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.
-
Software Traceability Matrix (IEC 62304)
€69.00Active Excel traceability matrix linking requirements, architecture, tests, risk controls and anomalies, with auto-calculated coverage summary.
-
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.
-
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.
-
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.
