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ISO 13485 Quality Management System for Medical Devices

Efficient medical device quality management and testing

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 reason, 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 organisations 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.

As of 19 December 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. Companies with existing ISO 13485 certificates will need to upgrade their certification to the new standard by 31 Mar 2019. The certificates issued henceforth will carry a three-years validity until the cessation date of the superseded standard is being published by European Commission. After which, the validity date will be the day of cessation. Manufacturers holding certificates covering a longer period will need to prepare ahead and ensure an upgrade to ISO 13485:2016 before the cessation date.

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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. Learn more about our ISO 13485 certification services.

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