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Technical Files

IVDR Technical File Template Package

4.8 (47 reviews)

Comprehensive technical documentation template aligned with IVDR Annexes II and III requirements. Includes sections for device description, intended purpose, design verification, manufacturing process, and post-market surveillance. Suitable for all risk classes with guidance on how to tailor content based on classification.

IVDR Articles Covered:

Article 10Annex IIAnnex III

What's Included:

  • Complete technical file structure per Annex II/III
  • Pre-filled guidance text and instructions
  • Sections for all risk classes A-D
  • Traceability matrix templates
  • Version control and document management guidance
File Formats

DOCX, PDF

License

Single organization license

€249.00Instant download after purchase

Instant digital delivery • Money-back guarantee

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