Sorry for the vagueness of this question (I'm from a device background and know nothing of the pharma side)....
If an EU pharmaceutical company were to move into the world of devices, what changes would they need to make from a quality and regulatory perspective? I see that there is a directive (2003/94/EC) which relates to GMP in europe but my quick skim through seemed to suggest that it wasn't a complete QMS like 13485.
If an EU pharmaceutical company were to move into the world of devices, what changes would they need to make from a quality and regulatory perspective? I see that there is a directive (2003/94/EC) which relates to GMP in europe but my quick skim through seemed to suggest that it wasn't a complete QMS like 13485.
