GP-016 Traceability and identification
Purpose
To describe the methodology to establish the general rules that allow the identification of the product status, as well as to determine the procedure to guarantee the traceability of the finished product.
Scope
All the medical devices that we manufacture.
Definitions
- EMDN: European Medical Device Nomenclature
- GMDN: Global Medical Device Nomenclature
- UDI: Unique Device Identifier. The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific device on the market. The UDI is comprised of the UDI-DI and the UDI-PI.
- UDI-DI: UDI device identifier. The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.
- UDI-DI basic: The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.
- UDI-PI: The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.
Responsibilities
JD-001
To provide the organization and its members with the necessary resources to carry out their obligations in the most efficient way possible.
To validate the sales forecast and the necessary product availability.
JD-005
To identify the status of the existing devices and the correct allocation of the UDI number and software versions to the manufactured products according to the coding system described in this document.
To release the finalized products.
JD-003
To define the state identification of the product and to organize the product development team to ensure the products are developed according to the establish procedures described within the Quality Management System.
JD-004
To elaborate the system of identification of the state of the product, to ensure the product development team register all the production records according to the established procedures and to review these records to guarantee the traceability of the manufactured products.
Inputs
- Contracts with clients signed
T-011-001 Device OAuth order
Outputs
T-012-012 Customers product version control