Medical Device Quality Management System Certification
ISO 13485 is the harmonized standard for Quality Management System (QMS) in the medical device industry.
In this document:
Understanding Medical Device Quality Management System Certification
EN ISO 13485 and CE marking
The importance of EN ISO 13485
Why choose BSI?
Let's shape your organization's future together
Reach out and see how we can help guide you on your path to sustainable operational success.