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Risk Management File Template
Technical Files

Risk Management File Template

4.8 (41 reviews)

Complete risk management file template based on ISO 14971 and IVDR requirements. Includes risk analysis worksheets, FMEA templates, risk-benefit analysis, and risk management report structure.

IVDR Articles Covered:

Article 10(2)Annex I Chapter I

What's Included:

  • ISO 14971:2019 aligned structure
  • Risk analysis worksheets with hazard library
  • FMEA and FTA templates
  • Risk-benefit analysis framework
  • Residual risk evaluation matrices
File Formats

DOCX, XLSX, PDF

License

Single organization license

€219.00Instant download after purchase

Instant digital delivery • Money-back guarantee

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