Dear experts,
Anyone who can explain me rule 11?
I think it applies to standalone sw only but what is exactly a stand alone sw? Our device is probably considered a stand alone software (radiation planning) by itself, but it is used then by other software for treatment. So...is it really a standalone??
The two software have two separate DoC. What do you think? Does rule 11 still applies?
Anyone who can explain me rule 11?
I think it applies to standalone sw only but what is exactly a stand alone sw? Our device is probably considered a stand alone software (radiation planning) by itself, but it is used then by other software for treatment. So...is it really a standalone??
The two software have two separate DoC. What do you think? Does rule 11 still applies?