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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ISO 14971 risk management extended with AAMI CR34971 guidance on AI/ML-specific hazards (drift, automation bias, generalisation failure).

Active Excel template for Design FMEA aligned with EN ISO 14971:2019/A11:2021. Auto-calculated RPN, automatic Region classification (Acceptable / AFAP / Unacceptable), conditional formatting and three worked examples.

Word template for the Hazard Analysis implementing the full ISO/TR 24971:2020 Annex A questionnaire (46 questions). Systematically identifies hazards across the device lifecycle.

Risk Management SOP with Plan, Report, Risk Analysis Matrix (Excel with auto-RPN formulas), and URRA per IEC 62366-1. Aligned with ISO 14971:2019/A11:2021.

The complete risk management documentation kit aligned with EN ISO 14971:2019/A11:2021, IEC 62366-1 and EU MDR Annex I. Six coordinated templates: Risk Management Plan and Report, Hazard Analysis, Design FMEA, Use-related FMEA and General Safety and Performance Requirements Checklist. Save 16% vs buying individually.

Word template for the Risk Management Plan per EN ISO 14971:2019/A11:2021. Defines the process, scoring scales, acceptability thresholds and competence matrix. The framework all other risk documents reference.

Word template for the Risk Management Report per EN ISO 14971:2019/A11:2021. Documents the execution of the RMP, summarises residual risks and concludes on the benefit-risk balance.

Active Excel traceability matrix linking requirements, architecture, tests, risk controls and anomalies, with auto-calculated coverage summary.

Active Excel template for Use-related FMEA aligned with EN IEC 62366-1:2015/A1:2020. Includes User Profiles & Use Environments, auto-calculated RPN and three worked examples.
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