QMS Documentation Suite for IVDR

4.7 (23 reviews)

Comprehensive Quality Management System documentation package aligned with ISO 13485 and IVDR Article 10(8) requirements. Includes quality manual template, procedure templates, and form templates.

IVDR Articles Covered:

Article 10(8)Article 10(9)

What's Included:

Quality Manual template (ISO 13485 aligned)
15+ essential procedure templates
Process flowcharts and work instructions
Record and form templates
IVDR-specific QMS requirements mapping

File Formats

DOCX, PDF, XLSX

License

Single organization license

€399.00Instant download after purchase

Instant digital delivery • Money-back guarantee