ISO 13485 Standards for Quality Management System on Medical Devices
Develop a management system focused on trust
The medical device business is grounded in trust. Before a device is used on a patient, it must first win the trust of many stakeholders. From medical staff, hospitals, and healthcare institutions to regulators and often the public themselves.
A quality management system is integral to this chain of trust. It ensures that your medical products consistently meet customer expectations of quality, safety, and performance.
TÜV SÜD’s Quality Management auditing certificates show that you comply with the requisite international standards such as ISO 13485. This is proof that your products have been manufactured under a certified quality management system.
Our auditors have an established history of assessing leading medical device manufacturers. We know how to assess your operational efficiency.
Your Medical Device System partner for:
ISO 13485 Quality Management System – Medical Device
ISO 9001 Quality Management System – General
ISO 14001 Environmental Management
Japan GMP (JGMP)
Facility Inspection for NRTL, GS-Mark, etc.
Good Dialysis Practice, quality and application rules standard for dialysis clinics
Your benefits at a glance
Improve your process quality and transparency
Ensure quality, safety and performance of your devices
Raise brand reputation and consumer trust and satisfaction
Avoid costly product recalls by delivering consistent quality and safety