Quality Management & Quality Control for Medical Device

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:

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