ISO 13485 is the internationally recognized standard for Medical Device Quality Management Systems and provides the framework for the design, development, production, installation, and delivery of medical devices and ensure they are safe for their intended purpose. It is more prescriptive in nature than ISO 9001 and requires a more thoroughly documented quality management system with an added focus on demonstrating regulatory compliance in all applicable jurisdictions.
See also the
MDSAP Information.
See also the
MDR/IVDR Information.
