Need some help figuring out UDIs...
My company distributes a tablet computer with proprietary software loaded on it that is used to program one of our implantable devices. This programmer (tablet+SW) is only distributed to company field representatives, not to end users, and is one of several components used with the "system". The SW is not distributed separately,except in cases of an upgrade, in which the company representative will upload the new version of the SW onto the tablet/programmer. Users do not receive the software directly. Questions about UDIs:
1) Does the SW itself need a UDI (to be displayed on the startup or about screen)?
1a) If yes, does the UDI need to change if the SW revision changes (major revision with new features or user interface changes)?
1b) If yes, does the UDI need to change if the SW revision changes (minor bug fixes, no new features or user interface changes)?
2) Does the "programmer" (tablet computer+SW) require a UDI? It is only used as part of the medical device system and not as a regular computer, etc.
Hoping someone who works with devices that have a separate programmer (e.g. pacemakers, neuromodulation devices, etc.) has some insight for me. Thank you!
My company distributes a tablet computer with proprietary software loaded on it that is used to program one of our implantable devices. This programmer (tablet+SW) is only distributed to company field representatives, not to end users, and is one of several components used with the "system". The SW is not distributed separately,except in cases of an upgrade, in which the company representative will upload the new version of the SW onto the tablet/programmer. Users do not receive the software directly. Questions about UDIs:
1) Does the SW itself need a UDI (to be displayed on the startup or about screen)?
1a) If yes, does the UDI need to change if the SW revision changes (major revision with new features or user interface changes)?
1b) If yes, does the UDI need to change if the SW revision changes (minor bug fixes, no new features or user interface changes)?
2) Does the "programmer" (tablet computer+SW) require a UDI? It is only used as part of the medical device system and not as a regular computer, etc.
Hoping someone who works with devices that have a separate programmer (e.g. pacemakers, neuromodulation devices, etc.) has some insight for me. Thank you!