Hi, not really MDR stuff, but a EU regulation. Just wonder what we need to update for our QMS? In our clinical evaluation SOP we have a statement that it is not allowed for us to collect personal patient data - only the hospitals/medical doctors shall know the patients; for us they are just numbers...
Is there anything else we should consider?
(we don't use software as a medical device)
Thanks!
Wolf
Is there anything else we should consider?
(we don't use software as a medical device)
Thanks!
Wolf