Greetings,
I have a question or two regarding the validation process of OTS software that is used by our medical device, which is also software.
For example, if our device required Adobe Flash to play loops of ultrasound images (viewer), would we have to validate the player by itself and then validate the viewer?
Or, is just the overall validation of the entire device enough to satisfy the requirements of validating OTS software?
Regards, Tonia
I have a question or two regarding the validation process of OTS software that is used by our medical device, which is also software.
For example, if our device required Adobe Flash to play loops of ultrasound images (viewer), would we have to validate the player by itself and then validate the viewer?
Or, is just the overall validation of the entire device enough to satisfy the requirements of validating OTS software?
Regards, Tonia