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Modules/Regulatory Affairs/Declarations of Conformity
Regulatory Affairs

Declarations of Conformity

Create, manage, and maintain EU Declarations of Conformity as required by EU MDR Article 19. Ensure your DoC documents are complete, accurate, and updated whenever changes affect conformity, with templates that cover all required elements.

Key Capabilities

What you get with the Declarations of Conformity module.

DoC templates aligned with EU MDR Annex IV requirements
Multi-device DoC management with product and classification tracking
Version control with change triggers when standards or products are updated
Notified body certificate linkage for devices requiring third-party assessment
DoC publication and distribution tracking for regulatory compliance

How It Connects

Declarations of Conformitydoesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.

Ready to see Declarations of Conformity in action?

Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how Declarations of Conformity works within your specific compliance context.

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