Advisory Notice and FSCA — Process Package (ISO 13485)
€69.00Advisory Notice / FSCA SOP with FSCA Decision Worksheet and Field Safety Notice (FSN) per MDCG 2024-1.
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CAPA SOP + Template — ISO 13485, MDSAP & FDA QMSR Compliant
€69.00Process Package — Corrective and Preventive Action (CAPA) A complete CAPA system covering ISO 13485:2016 §8.5.2–8.5.3, MDSAP Chapter 1–2, and FDA QMSR expectations. CAPA is the most-cited finding area in regulatory audits — this package addresses it head-on with a lifecycle-complete template and a procedure that integrates risk-based prioritization. What’s included: SOP-CORE-04 CAPA — full…
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Change Control — Process Package (ISO 13485)
€69.00Change Control SOP with comprehensive Change Form including MDCG 2020-3 substantial change assessment matrix.
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Clinical Evaluation — Process Package (ISO 13485)
€69.00Clinical Evaluation SOP with CEP and CER templates. Aligned with EU MDR Annex XIV + MDCG 2020-5 (equivalence) + MDCG 2020-13 (CEAR).
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Complaint Management — Process Package (ISO 13485)
€69.00Complaint Management SOP with Complaint File template that INTEGRATES the 4-question Reportability Assessment per Art. 87.
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Complete ISO 13485 QMS Documentation Kit (30 Packages + Quality Manual + Master Tracker)
€499.00Complete ISO 13485 QMS Documentation Kit — All 30 Process Packages + Quality Manual + Master Tracker. Aligned with ISO 13485:2016, EU MDR 2017/745, FDA QMSR, and MDSAP.
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Computer System Validation — Process Package (ISO 13485)
€69.00Computer System Validation SOP with Validation Plan & Report and IQ/OQ/PQ Protocol templates. Aligned with GAMP 5 and 21 CFR Part 11.
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Corrective and Preventive Action — Process Package (ISO 13485)
€69.00CAPA SOP with comprehensive CAPA Template covering full lifecycle: Initiation, Triage, Root Cause Analysis, Action Planning, Implementation, Effectiveness Verification.
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Customer Related Processes — Process Package (ISO 13485)
€69.00Customer-Related Processes SOP with Customer Order / Contract Review Form (per ISO 13485 §7.2.2).
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Design and Development Control — Process Package (ISO 13485)
€69.00Design and Development Control SOP with 6 templates: Plan, I/O Matrix (Excel), Review Record, Verification, Validation, Transfer Checklist. Largest package in the kit.
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Document and Record Control — Process Package (ISO 13485)
€69.00Audit-ready Document Control SOP plus 3 templates: Master List, Change Request Form, and Record Destruction Authorization. Aligned with ISO 13485:2016 §4.2 and 21 CFR Part 11.
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Document Control SOP + Templates — ISO 13485 & MDSAP Compliant
€69.00Process Package — Document and Record Control A complete, audit-ready document control system covering all requirements of ISO 13485:2016 §4.2.4–4.2.5, MDSAP Chapter 1, and 21 CFR Part 11 for electronic records. What’s included: SOP-CORE-01 Document and Record Control — full standard operating procedure with cover page, control page, responsibilities matrix, document hierarchy, lifecycle workflow, periodic…
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EU Vigilance Reporting — Process Package (ISO 13485)
€69.00EU Vigilance Reporting SOP with PSUR template (per MDCG 2022-21). Covers Art. 87-92 reporting timelines and EUDAMED submission.
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Human Resources and Training — Process Package (ISO 13485)
€69.00HR + Training SOP with Job Description (PRRC role), Training Plan & Record (Excel), and Competence Matrix (16 pre-populated competences).
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Incoming Inspection and Control — Process Package (ISO 13485)
€69.00Incoming Inspection SOP with Inspection Plan & Report (Excel) and CoA/CoC Review Record. AQL sampling per ANSI/ASQ Z1.4.
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Infrastructure and Equipment Control — Process Package (ISO 13485)
€69.00Infrastructure & Equipment Control SOP with Equipment Master List (Excel — auto-calc Days Until Cal) and Maintenance & Calibration Record.
