mdr-expert.com
Additional information
Engaging with mdr-expert.com for EUDAMED onboarding typically involves a structured approach to data collection and submission. Buyers should be prepared to provide detailed information about their medical devices, including UDI assignments and technical documentation. The process emphasizes accuracy and completeness to ensure successful registration and compliance with EU MDR and IVDR regulations.
Buyer Snapshot
Best for
- Medical device manufacturers seeking EUDAMED registration support
- Companies needing guidance on EU MDR/IVDR compliance
How engagement typically works
- Consultative support for regulatory processes
- Data preparation and submission assistance
Typical deliverables
- EUDAMED registration guidance
- Data submission support
Good to know
- Best when clients have foundational device information ready for submission
Status:
listed
Services & Capabilities
EUDAMED Onboarding & Data Registration Support (Mandatory Modules)
Modules Supported:
Actor/SRN, UDI/Devices, Certificates
Submission Approach:
Portal, Bulk Submissions
Portfolio Fit:
26-100
Onboarding Speed:
6+ weeks
Managed Service Available:
Yes
Integration Support:
ERP/PLM mapping, Labeling mapping
Additional eudamed_onboarding_support Details
Modules Supported
Actor/SRN, UDI/Devices
Submission Approach
Portal operations
