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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Usability Engineering — Process Package (ISO 13485)
€69.00Usability Engineering SOP with Use Specification & URRA combined and Usability Engineering File (UEF) Summary. Aligned with IEC 62366-1 + FDA HFE 2016.