ISO 13485
A quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
This International Standard can also be used...
MDSAP
The MDSAP or Medical Device Single Audit Program is a program for companies that sell product in multiple countries. MDSAP is especially designed for organizations operating with multiple sites and in multiple markets. MDSAP is a way that medical device...