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 5 results
-
-
Data Governance & Bias Management Plan (AI-02)
€69.00Data sourcing, representativeness, dataset independence and bias identification & mitigation across the AI lifecycle.
-
Model Validation & Performance Report (AI-03)
€69.00Standalone performance evaluation plus subgroup/sub-population analysis, with the methodology reviewers expect across five markets.
-
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.
-
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.