Managing the UDI allocation system for all of Biometrix and Degania products according to relevant regulatory and UDI accredited agencies requirements.
Key Responsibilities:
UDI – Unique Device Identifier, means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;
The UDI officer shall be responsible for
• the UDI assignment and placement of the UDI carrier,
• the initial submission and updates of the identifying information and other device data elements in the regulatory databases (i.e, GUDID for the FDA, EUDAMED for CE marked products and/or any other regulatory database needed),
• Coordinate the information internally and externally based on current regulations and with the accredited issuing agency