Dear experts,
Greetings!
I would like to understand the differences and relation between the undesirable side-effects, side-effects, harms and risks of a device.
Also, how to address undesirable side-effects in CER to comply with essential requirements ER 3.
It would be really helpful if explained with an example.
Thanks in advance!
Harini
Greetings!
I would like to understand the differences and relation between the undesirable side-effects, side-effects, harms and risks of a device.
Also, how to address undesirable side-effects in CER to comply with essential requirements ER 3.
It would be really helpful if explained with an example.
Thanks in advance!
Harini