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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Summary of Safety and Clinical Performance (SSCP) Template – MDR
€69.00Word template for the SSCP per EU MDR Article 32. Required for Class III and implantable devices, suitable for Eudamed publication.
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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.
