IVDR Compliance Templates

Professional, ready-to-use templates to accelerate your EU IVDR compliance journey.

Showing 10 templates

Clinical Evidence Report Template

Performance Evaluation

Clinical Evidence Report Template

Post-Market Surveillance Plan Template

Technical Files

Post-Market Surveillance Plan Template

Complete IVDR Compliance Bundle

Complete IVDR Compliance Bundle

DOCX, XLSX, PDF

Risk Management File Template

Technical Files

Risk Management File Template

DOCX, XLSX, PDF

QMS Documentation Suite for IVDR

QMS Documentation

QMS Documentation Suite for IVDR

DOCX, PDF, XLSX

EU Declaration of Conformity Template

Declaration of Conformity

EU Declaration of Conformity Template

Performance Evaluation Report Template

Performance Evaluation

Performance Evaluation Report Template

Performance Evaluation Plan Template

Performance Evaluation

Performance Evaluation Plan Template

GSPR Compliance Checklist (Annex I)

GSPR Checklists

GSPR Compliance Checklist (Annex I)

IVDR Technical File Template Package

Technical Files

IVDR Technical File Template Package