Internal Audit — Process Package (ISO 13485)
€69.00Internal Audit SOP with Annual Audit Programme (Excel), Audit Plan, and Audit Report templates. Covers ISO 13485 §8.2.4 and FDA QMSR.
Showing 17–32 of 37 results
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Internal Audit SOP + 3 Templates — ISO 13485 & MDSAP Compliant
€69.00Process Package — Internal Audit A complete internal audit system covering ISO 13485:2016 §8.2.4 and MDSAP Chapter 1 audit-readiness expectations. Risk-based programme planning, structured audits, and findings management with linkage to CAPA. What’s included: SOP-CORE-03 Internal Audit — full procedure including risk-based programme rationale, audit team competence, planning, conduct, reporting, NC grading methodology (5-tier per…
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KPI and Data Analysis — Process Package (ISO 13485)
€69.00KPI SOP with KPI Catalog & Dashboard (Excel — 23 pre-populated KPIs, 90 auto-calc formulas) and Quality Objectives Tracker.
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Labelling and Translation Management — Process Package (ISO 13485)
€69.00Labelling and Translation Management SOP with combined Label Specification + IFU + Approvals + Translation Validation template. Aligned with EU MDR Annex I §23 + ISO 15223-1 + ISO 20417.
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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.
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Management Review SOP + Template — ISO 13485 & MDSAP Compliant
€69.00Process Package — Management Review Complete, audit-ready management review system covering ISO 13485:2016 §5.6 and MDSAP Chapter 1 expectations. Includes the 17 mandatory review inputs, output decisions framework, and integration with CAPA and KPI processes. What’s included: SOP-CORE-02 Management Review — full procedure with frequency, agenda structure, input checklist (all 17 ISO §5.6 inputs), output…
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MDSAP Documentation Kit — 15 SOPs + 18 Templates for All 5 Jurisdictions (BR · JP · CA · AU · USA)
€399.00MDSAP Documentation Kit — Complete The flagship kit. Everything your QMS needs to face an MDSAP audit confidently across all 5 jurisdictions: Brazil, Japan, Canada, Australia, USA. 15 procedures + 18 templates + a User Guide and Master Index, all aligned to the latest 2025-2026 regulatory frameworks. What’s included: Shared Core (4 procedures + 8…
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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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SOP — AI/ML Model Development & Lifecycle (AI-09)
€69.00The procedural SOP your ISO 13485 QMS requires: roles, steps and stage gates for AI/ML model development, built on ISO 13485 §7.5 and GMLP.
