A
I am trying to find out if there are any specific regulations for either Medical device software or IVD device software to display the version number of the software? I was of the understanding that this must be displayed in the initial "flash" screen and also the "about" dialogue box but can't find a specific reference in either EU directives, harmonized standards or FDA guidance.
Is there a minimum time that the "flash" screen should be displayed?
Also, what happens if there are "plug ins" that are optional to the user of the device?
Thanks, any help would be appreciated.....
Is there a minimum time that the "flash" screen should be displayed?
Also, what happens if there are "plug ins" that are optional to the user of the device?
Thanks, any help would be appreciated.....