Hi There, I have a quick question regarding the validation of Software used under scope, in relation to
13485:2016, Particularly sections 4.1.6, 7.5.6 and 7.6
Does Software used to create the Software that is used under scope (e.g Visual Studio, used to create a Application used in Production) need to be validated?
Seem to be having a lot of confusion on what precisely needs to be validated, The Actual app used in production, or the software used to make the App
Any help here would be appreciated!
13485:2016, Particularly sections 4.1.6, 7.5.6 and 7.6
Does Software used to create the Software that is used under scope (e.g Visual Studio, used to create a Application used in Production) need to be validated?
Seem to be having a lot of confusion on what precisely needs to be validated, The Actual app used in production, or the software used to make the App
Any help here would be appreciated!