S
sara_jg
Hello,
For one of our medical device we are having two software's, one is pc based software which is used to view the measurements and another which is the firmware for the device.
My doubt is whether we need to follow PEMS documentation as per IEC 62304 for both the software for only for the firmware?
Please help.
Thank you
sara
For one of our medical device we are having two software's, one is pc based software which is used to view the measurements and another which is the firmware for the device.
My doubt is whether we need to follow PEMS documentation as per IEC 62304 for both the software for only for the firmware?
Please help.
Thank you
sara