GSPR Compliance Checklist (Annex I)

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Detailed checklist covering all 23 General Safety and Performance Requirements from IVDR Annex I. Each requirement includes compliance evidence suggestions, applicable standards references, and space for documentation references. Essential for systematic GSPR assessment and Notified Body audits.

IVDR Articles Covered:

Annex IArticle 5

What's Included:

All 23 GSPRs covered systematically
Evidence documentation guidance
Applicable harmonized standards listed
Risk class-specific requirements highlighted
Ready for NB audit submission

File Formats

XLSX, PDF

License

Single organization license

€149.00Instant download after purchase

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