Regulatory Consulting: Support in the UDI (Unique Device Identification) assignation process
Service Description
IPN provides services related to the Unique Device Identification (UDI) system, which ensures proper traceability of the devices throughout the distribution chain and by the user. IPN assists in the registration of organizations within an accredited UDI issuing agency, in the creation and correct use of UDI codes (UDI-DI, UDI-PI and basic UDI), ensuring that UDI data is formatted correctly for submission to EUDAMED and/or Global Unique Device Identification Database (GUDID – FDA). IPN also provides support in the maintenance of data related to the UDI.
Keywords:
UDI
EUDAMED
Offerings:
Ethics & Regulatory Affairs
Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.)
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)