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.
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AI Risk Management Plan & Report (AI-04)
€69.00ISO 14971 risk management extended with AAMI CR34971 guidance on AI/ML-specific hazards (drift, automation bias, generalisation failure).
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AI/ML Medical Device Documentation Kit – Complete Bundle
€499.00All 10 AI/ML documents + README + Master Index (Excel). One coordinated set, five markets. Save ~28% vs buying individually.
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Clinical Evaluation Plan — AI-Augmented (AI-08a)
€69.00A clinical evaluation plan on a real CEP template, with AI-specific additions flagged as [AI MODULE] for integration with your clinical process.
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Clinical Evaluation Report — AI-Augmented (AI-08b)
€69.00The reporting counterpart to AI-08a on a real CER template with [AI MODULE] markers, documenting the AI clinical evidence and benefit-risk contribution.
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Data Governance & Bias Management Plan (AI-02)
€69.00Data sourcing, representativeness, dataset independence and bias identification & mitigation across the AI lifecycle.
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EN 18286 in Practice: The Quality Management System Required by the EU AI Act
€229.00EN 18286 · EU AI Act Article 17 · ISO 13485 EN 18286 in Practice: The Quality Management System Required by the EU AI Act All 146 requirements of the standard, clause by clause — each one mapped to the document, record or decision it obliges you to hold. €229 VAT calculated at checkout Get…
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Human Oversight & Transparency Plan (AI-06)
€69.00GMLP principles P7/P9 plus the Transparency guiding principles and EU AI Act Articles 13–14, in one coordinated plan.
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Model Validation & Performance Report (AI-03)
€69.00Standalone performance evaluation plus subgroup/sub-population analysis, with the methodology reviewers expect across five markets.
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Postmarket AI Performance Monitoring (AI-07)
€69.00Real-world performance monitoring: drift detection, logging strategy and re-training triggers feeding back into the PCCP and risk file.
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Predetermined Change Control Plan — PCCP (AI-05)
€69.00The flagship PCCP — pre-authorised modifications, modification protocol and impact assessment, aligned to FDA and Health Canada nomenclature.
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SOP — AI/ML Model Development & Lifecycle (AI-09)
€69.00The procedural SOP your ISO 13485 QMS requires: roles, steps and stage gates for AI/ML model development, built on ISO 13485 §7.5 and GMLP.
