A
Dear all,
My company is going to manufacture a class I active medical device which have software in it.
This is the first time my company is manufacturing an active medical device with software.
Can anybody advice how to perform software validation?
I am aware there is a guidance doc from US FDA on software validation. Does EU have a similar guidance doc?
Best regards,
Arnthor
My company is going to manufacture a class I active medical device which have software in it.
This is the first time my company is manufacturing an active medical device with software.
Can anybody advice how to perform software validation?
I am aware there is a guidance doc from US FDA on software validation. Does EU have a similar guidance doc?
Best regards,
Arnthor