Management Review — Process Package (ISO 13485)
€69.00Audit-ready Management Review SOP with combined Agenda + Minutes template. Covers all 17 mandatory ISO 13485 §5.6 inputs.
Showing 17–30 of 30 results
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Medical Device File — Process Package (ISO 13485)
€69.00Medical Device File SOP with MDF Index template aligned with EU MDR Annex II §1-6 + Annex III.
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Nonconformance Management — Process Package (ISO 13485)
€69.00Nonconformance Management SOP with NC Report template (severity classification, RCA, disposition).
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Notified Body Change Notification — Process Package (ISO 13485)
€69.00Notified Body Change Notification SOP with comprehensive NB Change Notification Form per EU MDR Art. 56(2) + MDCG 2020-3 Rev.2.
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Post-Market Surveillance — Process Package (ISO 13485)
€69.00Post-Market Surveillance SOP with PMS Plan and PMS Report (Class I) templates. Aligned with EU MDR Art. 84-86 + Annex III + MDCG 2022-21.
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Process Validation — Process Package (ISO 13485)
€69.00Process Validation SOP with VMP, IQ/OQ Protocol, and PQ Protocol & Report templates. Aligned with FDA Process Validation Guidance 2011 (Stage 1-2-3).
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Production and Service Provision — Process Package (ISO 13485)
€69.00Production and Service Provision SOP with Manufacturing Process Specification (MPS) — equivalent to FDA Device Master Record (DMR).
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Purchase Management — Process Package (ISO 13485)
€69.00Purchase Management SOP with combined Purchase Specification + PO template (Part A specs + Part B PO).
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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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Sterilization Process Validation — Process Package (ISO 13485)
€69.00Sterilization Process Validation SOP — supplier-provided validation framework per ISO 11135/17665/11137. SOP only (no templates — supplier provides validation docs).
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Strategy for Regulatory Compliance — Process Package (ISO 13485)
€69.00Strategy for Regulatory Compliance SOP with PRRC Qualification Record per EU MDR Art. 15(1) — pathway (a) or (b).
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Supplier Management — Process Package (ISO 13485)
€69.00Supplier Management SOP with Evaluation Form, Approved Supplier List (Excel), and bilateral Quality Agreement.
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UDI Management — Process Package (ISO 13485)
€69.00UDI Management SOP with UDI Master List (Excel) for EUDAMED + FDA GUDID submission tracking.
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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.