Choose another country to see content specific to your location

//Select Country

ISO 13485 Certification

Improve your process quality and transparency

ISO 13485 Certification

Improve your process quality and transparency

Develop a management system focused on trust

The update to ISO 13485:2003, the internationally recognized quality management systems standard for the medical device industry, with over 27,000 certificates globally, was published on February 25, 2016.

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
  • 93/42/EEC (MDD)
  • 98/79/EC (IVDD)
  • 90/385/EEC (AIMD)
  • 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


Smart healthcare

Smart Healthcare

New technology for successful ageing

Learn more

White paper

ISO 9001:2015

This whitepaper outlines the new updates to ISO 9001:2015.

Learn more


Next Steps

Select Your Location





Middle East and Africa