What is the process and Quality Management Systems for these changes?
Updating of the GMDN Database is monitored and controlled by an ISO9001 Quality Management System.
Updating of the GMDN Database is monitored and controlled by an ISO9001 Quality Management System.
The IMDRF defines personalized medical devices, including Custom-made, patient-matched, and adaptable devices according to IMDRF/PMD
If you can’t find a GMDN Term that is appropriate for your product, you can
Regulators and Conformity Assessment Bodies know the process for new Term requests used by the
All client information contained in the GMDN Database is password protected, encrypted and not available
“Code Credits” are for Basic members and paid Manufacturer and Consultancy or Commercial Organisation members,
The GMDN Codes are protected so that most members can only see Codes relevant to
Multi-user access is managed within the GMDN Database by the ‘Users’ function, found in the
If a member wishes to change the GMDN Code selected for a particular product, it
The Manufacturer is responsible for assigning the correct GMDN Term to their device because they