Showing 17–20 of 20 results
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.
Word template for the SSCP per EU MDR Article 32. Required for Class III and implantable devices, suitable for Eudamed publication.
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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