What is your experience with safety compliance overseas?
I was trying to as ask John, VP from element 14. After trying a few times of clicking and got no where, I thought I try the community.
I know in the USA, it is important to get FDA 510K clearance, some IEC 62304, 60601 depends if you are hardware or software.
How about in Europe? Some device only get CE. Is that all?
I am dping research to post findings to the MEDS Magazine.
John
