Regulatory Affairs

UDI Records

Manage Unique Device Identification records and ensure compliance with FDA UDI Rule, EU MDR UDI requirements, and other global UDI mandates. Maintain accurate device identifier data and keep your UDI database submissions current across all required markets.

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Part of Regulatory Affairs

ISO Templates Post-Registration Review Inspection Readiness Implant Cards Device Master Records Site Security Plans Product Registrations GUDID Submissions Declarations of Conformity CE Marking Procedures Essential Requirements Technical Documentation Regulatory Submissions Economic Operators Regulatory Commitments Regulatory Intelligence EUDAMED Reports Notified Body Management

Key Capabilities

What you get with the UDI Records module.

UDI-DI and UDI-PI management with production identifier tracking

GUDID and EUDAMED submission readiness with data validation checks

Multi-market UDI compliance tracking for FDA, EU, and other jurisdictions

Label UDI verification ensuring consistency between records and physical labels

UDI change management triggered by product or packaging modifications

See Regulatory Affairs in action

Watch how MoniDoseQMS handles regulatory affairs workflows end-to-end.

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Getting Started

Build your own QMS

Register an account and assemble your quality system from only the modules you need — set up in minutes, with no implementation fee.

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Getting Started

Platform tour

A guided tour of MoniDoseQMS after you log in — your profile, the everyday tools (notifications, recycle bin, tasks, events, regulatory news), and the dashboard.

How It Connects

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

Label Masters GUDID Submissions EUDAMED Reports

Ready to see UDI Records in action?

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

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More in Regulatory Affairs

Explore other modules in the Regulatory Affairs category.

ISO Templates

Access a comprehensive set of ISO-compliant document templates that cover the full scope of your quality management system. Save weeks of preparation with templates structured to meet ISO 13485, ISO 14971, and other critical standards out of the box.

Post-Registration Review

Evaluate changes to registered products to determine if regulatory submissions or notifications are required. Streamline your post-registration review process to ensure changes are assessed against global regulatory requirements before implementation.

Inspection Readiness

Stay prepared for regulatory inspections at all times with a centralized readiness dashboard and structured preparation checklists. Identify gaps before inspectors arrive and ensure your team is confident, organized, and audit-ready.

Implant Cards

Generate and manage implant cards as required by EU MDR Article 18 for implantable medical devices. Ensure patients receive the required identification information including device details, UDI, and essential safety information.

Device Master Records

Compile and maintain Device Master Records (DMR) containing all specifications, procedures, and instructions needed to manufacture your products. Ensure your DMR is complete, current, and readily accessible for production and regulatory purposes.

Site Security Plans

Develop and maintain site security plans that protect your manufacturing facilities, products, and intellectual property. Document access controls, threat assessments, and emergency procedures to ensure physical security compliance for regulated production environments.