🇪🇺 EUDAMED COMPLIANCE - Sterling Medical Registration

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Simplify your EU MDR compliance with expert EUDAMED support. Sterling Medical Registration provides Full-service support for manufacturers and importers navigating the European Database on Medical Devices (EUDAMED). From account setup to device registration and ongoing maintenance, we ensure your data is accurate, compliant, and audit-ready.

Sterling Medical Registration offers full-service support for manufacturers, authorized representatives, and importers navigating the European Database on Medical Devices (EUDAMED). Our services ensure smooth onboarding, accurate device registration, and ongoing compliance with EU MDR requirements.

🔹 Actor Registration & Account Setup

We assist in establishing your EUDAMED Actor account, including:

Guidance on selecting the correct actor role (manufacturer, authorized representative, importer)
Preparation and submission of required documentation
Coordination Single Registration Number (SRN) issuance

🔹 Medical Device Registration

We support the registration of your medical devices in EUDAMED:

Uploading UDI and device data modules
Ensuring correct classification and data formatting
Managing updates and corrections to device entries

🔹 Account Maintenance & Compliance

Our ongoing support includes:

Monitoring regulatory updates and deadlines
Maintaining accurate and current device and actor data
Assisting with periodic reviews

🔹 Additional Services

Consulting on EU MDR labeling and documentation requirements
Coordination with notified bodies for conformity assessment

✅ What We Offer

	Service	Description
	Actor Account Setup	We help you register your organization and obtain your Single Registration Number (SRN).
	Device Registration	Upload and manage UDI/device data modules with full compliance to EU MDR.
	Account Maintenance	Keep your actor and device data current with ongoing updates and regulatory monitoring.
	Labeling & Documentation Consulting	Ensure your labeling, IFUs, and technical files meet EU MDR and EUDAMED standards.
	Notified Body Coordination	Support for conformity assessment and integration with notified body documentation.
	Quality System Integration	Align your EUDAMED data with internal QMS for seamless compliance tracking.

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