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Kit Qualität Medizinprodukte

QMS und Zulassungsunterlagen: Designlenkung, CAPA, Risiko nach ISO 14971, Gebrauchstauglichkeit, Software-Lebenszyklus, MDR-Technische Dokumentation, CSV.

9 Vorlagen in 4 Schritten, in der Reihenfolge der Nutzung. Öffnen Sie eine Vorlage im Editor, füllen Sie sie aus und exportieren Sie sie als PDF, DOCX oder HTML.

Schritt 1

Grundlagen

  1. Medical Device Design Controls Template (ISO 13485)

    Standard

    Medical device design record (DHF)

    ISO 13485:2016 cl. 7.3; IEC 62366-1; IEC 62304; EU MDR 2017/745; 21 CFR 820 (QMSR)

  2. Nonconformity and Corrective Action (CAPA) Template

    Standard

    Nonconformity and CAPA record: description, containment, root cause, similar nonconformities check, actions, effectiveness, closure; ISO 13485 and QMSR notes

    ISO 9001:2026, ISO/IEC 27001:2022, ISO/IEC 42001:2023 (cl. 10.2); ISO 13485:2016 8.5.2
Schritt 2

Bewertungen

  1. Medical Device Risk Management File Template (ISO 14971)

    Standard

    Medical device risk management file: plan with acceptability criteria, safety characteristics, hazards, controls, overall residual risk, review, post-production loop

    ISO 14971:2019; ISO/TR 24971:2020

  2. Usability Engineering File Template (IEC 62366-1)

    Vollständig

    IEC 62366-1 usability file: use specification, known use problems, hazard-related use scenarios, formative and summative evaluation, root causes

    IEC 62366-1:2015+A1:2020

  3. Threat Model Template (STRIDE)

    Vollständig

    STRIDE threat model: scope, DFD with trust boundaries, assets, threats per element, L x I rating, mitigations, risk acceptance

    STRIDE
Schritt 3

Umsetzung

  1. Medical Device Software Lifecycle Template (IEC 62304)

    Vollständig

    IEC 62304 software file: safety class, development plan, requirements, architecture, SOUP list, testing, release, maintenance, problem resolution

    IEC 62304:2006+A1:2015

  2. GxP Computerised System Validation Plan Template (CSA, Annex 11, Part 11)

    Vollständig

    Risk-based CSV/CSA plan: intended use, GxP assessment, software category, risk scoring, supplier assessment, URS, testing, ALCOA+, Annex 11 and Part 11 mapping

    EU GMP Annex 11 (2011); 21 CFR Part 11; FDA CSA guidance (2026); GAMP 5 2nd ed. (cited)

  3. Verification and Validation Plan Template (IEEE 1012)

    Vollständig

    V&V plan: integrity level scheme, tasks per life-cycle phase, minimum tasks by level, independence, anomalies, reporting, schedule

    IEEE 1012-2024
Schritt 4

Regulierung und Compliance

  1. EU MDR Technical Documentation Template (Annex II and III)

    Vollständig

    EU MDR technical file index: classification, Annex II sections 1 to 6, GSPR checklist, V&V and clinical data, Annex III PMS plan and PSUR

    Regulation (EU) 2017/745 (MDR) Annexes II and III