T
Dear Cove,
I work for a major company making and distributing amon ther things medical xray scanners in Europe. Products are CE marked (as well as FDA approved...etc in most of the world)
Now, we have one customer that bought some xray equipment for research purposes. THey do not intent to use is as a medical device, will never scan patients or anything like this. They will scan some special types of stone.
THey have been asking us for a modified SW to accomodate their needs, however, some people in my organization claims this will violate the CE mark and is thus not allowed.
Can anyone guide me on this? Since the custoemr does not intend to use it as a medical device, is it possible legally to give the customer a modified SW version?
best regards
t.
I work for a major company making and distributing amon ther things medical xray scanners in Europe. Products are CE marked (as well as FDA approved...etc in most of the world)
Now, we have one customer that bought some xray equipment for research purposes. THey do not intent to use is as a medical device, will never scan patients or anything like this. They will scan some special types of stone.
THey have been asking us for a modified SW to accomodate their needs, however, some people in my organization claims this will violate the CE mark and is thus not allowed.
Can anyone guide me on this? Since the custoemr does not intend to use it as a medical device, is it possible legally to give the customer a modified SW version?
best regards
t.