Medical Devices and UDI
Samarind RMS’ optional Medical Device module enables users to track the regulatory information connected with medical devices.
Worldwide device and facility registrations, approvals and notifications can all be recorded and the system includes full support for the EU CE mark procedures, including automatic generation of the Declaration of Conformity (DoC).
A project planning facility is also available, which allows easy identification of all products and markets affected by any change.
US IFO/FEO compliance is also supported, as is submission of medical device information to the FDA’s Global Unique Device Identification Database, GUDID.
The Global Unique Device Identification Database (or short GUDID) is a searchable repository, at present administered by the Food and Drug Administration (FDA). It should serve as a reference catalogue for medical devices via an identifier. It is a requirement that each medical device, which is identified by the unique device identifier (or UDI), information concerning that device must be submitted to the GUDID.
At present, the GUDID only contains the device identifier (DI), which serves as the primary key to obtain device information from the repository. Production Identifiers (PI) are not submitted and/or stored in the GUDID. The GUDID itself can be accessed by the public to gain information about medical devices via different retrieval options.
Note that the medical devices module is currently only available in the Windows version of Samarind RMS.