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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Design FMEA (dFMEA) Template – MDR
€69.00Active 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.
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Hazard Analysis (HAN) Template – MDR
€69.00Word template for the Hazard Analysis implementing the full ISO/TR 24971:2020 Annex A questionnaire (46 questions). Systematically identifies hazards across the device lifecycle.
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MDR Complete Bundle
€999.00The complete EU MDR documentation set in one premium bundle. Three coordinated kits covering technical file, clinical evaluation and risk management. 22 templates total. Save 15% vs buying separately.
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Risk + Clinical Documentation Bundle – MDR
€599.00Save 20% by buying the Risk Management Documentation Kit and the EU MDR Clinical Documentation Kit together. Fourteen coordinated templates covering both halves of MDR Annex II in one purchase.
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Risk Management — Process Package (ISO 13485)
€69.00Risk 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.
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Risk Management Documentation Kit – MDR
€349.00The 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.
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Risk Management Plan (RMP) Template – MDR
€69.00Word 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.
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Risk Management Report (RMR) Template – MDR
€69.00Word 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.
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Use-related FMEA (uFMEA) Template – MDR
€69.00Active 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.
