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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.
Operational Excel checklist covering all 159 General Safety and Performance Requirements of MDR Annex I. Filterable, with applicability dropdown and color-coded compliance status.
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.
Save 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.
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 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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