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Regulatory Consulting: Support in registering on the EUDAMED database

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: 468c7ed7-87aa-42c3-b7a9-eaa15c626a4f

Service Description

The European database on medical devices (EUDAMED) improves transparency and coordination of information regarding medical devices available in the European market. The database consists of 6 modules, and IPN can assist organizations in using the modules already available, that is, in the registration of manufacturers, importers, and authorized representatives in the Actor Registration Module with the issue of the “Single Registration Number” (SRN), and in the device registration in the “UDI/Device Registration Module”

Offerings: Ethics & Regulatory Affairs Quality Management Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Development of conformity evaluation standards, protocols & tools
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Country Portugal
Published Email medicaldevices@ipn.pt
Billing: per hour
Full Price €85-150 EUR
Reduced Price €0-120 EUR
Pricing Detail

depending on seniority

Operational Details

Certification Support CE Marking (MDR, IVDR)