Regulatory Consulting: Support in registering on the EUDAMED database
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
Provider & Contact
Provider Organisation
Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)
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)