Validation of installtion CD

In my last place of employment (Medical Device), we validated installation CD’s that was a part of a medical device. Is this a requirement or good practice?

Certainly it’s a good idea no matter what. In the device world, I don’t know of anything that explicitly states it’s required. However, just remember (for medical devices), the system is to be validated to ensure it meets user needs and intended uses. If your system is delivered via CD and the customer does the install, then the CD and install process is part of the system. You might even consider the possibility that an improper installation could lead to a ‘device’ (software) failure. So in the device world, I would say that validation of the install CD is warranted.

Outside the device world (regulated industry), I guess it becomes more of a business decision.