ISO 13485 Certification

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.

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
  • 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


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