MaHoDie
Starting to get Involved
Hello everyone,
First of all, thanks for all the help and replies.
I found a couple of threads that have a similar topic but don't answer my question:
Is there anything to consider from a regulatory and legal point of view if I want to carry out a summative usability evaluation according to IEC 62366 (within the EU) with 5 - 10 healthcare professionals (no patients included! and corresponding labeling like RUO). Do you might know guideline documents e.g. from MDCG?
In my opinion I don't need an ethical approval for this, am I right?
It's about a web-application (SaMD/ MDSW).
A risk analysis according to ISO 14971 is carried out beforehand.
Thank you!
First of all, thanks for all the help and replies.
I found a couple of threads that have a similar topic but don't answer my question:
Is there anything to consider from a regulatory and legal point of view if I want to carry out a summative usability evaluation according to IEC 62366 (within the EU) with 5 - 10 healthcare professionals (no patients included! and corresponding labeling like RUO). Do you might know guideline documents e.g. from MDCG?
In my opinion I don't need an ethical approval for this, am I right?
It's about a web-application (SaMD/ MDSW).
A risk analysis according to ISO 14971 is carried out beforehand.
Thank you!