Hi all,
I have not had any experience with any ECO since I still do not have experience in the medical device industry. But to my understanding. some examples in which ECO is needed could be when a modification will have an effect:
– On the product- Maybe a correction of a design error that doesn’t become evident until testing and modeling, or customer use reveals it.
– On the manufacturing process- probably a change in material or manufacturing method. This can be caused by a lack of material availability, a change in vendor, or to compensate for a design error.