ISO 13485 Quality Management System for Medical Devices

Process Validation in Medical Devices

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Certify your quality management system for medical devices with ISO 13485

Perhaps more than any other type of manufactured product, the quality of medical devices has a direct impact on their effectiveness as well as the safety of patients, users, and where appropriate other persons. For these reasons, most national regulatory schemes require manufacturers and suppliers of medical devices to establish an internal quality management system that has been independently audited and verified. Medical devices manufactured or supplied by organizations without a verified quality management system are routinely denied legal entry into major markets, usually resulting in extended delays in gaining access and lost revenue opportunities.

Fulfill requirements with expert regulatory guidance. Complete the form to download the "Medical Device Guidance Document: Process Validation in Medical Devices".


TÜV SÜD offers a complete range of testing, certification and auditing services to manufacturers of medical devices, helping them to manage risks and to protect and promote the health and safety of patients, users, and where appropriate, other persons.

As of December 19, 2016, TÜV SÜD Product Service GmbH has been accredited by the German national accreditation body (DAkkS) to issue quality management system certificates to the latest edition of ISO 13485:2016. Learn more about our ISO 13485 certification services.

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