AI Development & Lifecycle Plan (AI-01)
€69.00Master AI/ML lifecycle plan integrating IEC 62304, IMDRF GMLP 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.
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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)
€69.00Clinical evaluation plan with AI-specific additions flagged as [AI MODULE].
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Clinical Evaluation Report – AI-Augmented (AI-08b)
€69.00The reporting counterpart to AI-08a, built on a real CER template with [AI MODULE] markers.
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Data Governance & Bias Management Plan (AI-02)
€69.00Data sourcing, representativeness, dataset independence and bias mitigation across the ML lifecycle.
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Human Oversight & Transparency Plan (AI-06)
€69.00GMLP P7/P9, the Transparency guiding principles and EU AI Act Articles 13-14 in one plan.
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Model Validation & Performance Report (AI-03)
€69.00Standalone and subgroup model performance evaluation, with methodology and acceptance criteria.
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Postmarket AI Performance Monitoring (AI-07)
€69.00Real-world performance monitoring: drift detection, logging strategy and re-training triggers.
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Predetermined Change Control Plan (AI-05)
€69.00The PCCP – pre-authorised model modifications so you can update post-clearance without a new submission.
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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.
