Medical Device Certification

As the use of medical devices can be life-threatening, they require special care in handling and their assured quality and safety must be guaranteed. Therefore, organizations which manufacture and sell medical devices/IVDs are required to conform to high standard manufacturing control and quality management systems, as well as safety standards.

The principle services TÜV-SÜD Japan Ltd. offers include the certification services of ISO 13485 (an international standard of quality management system), CE marking required for products sold in the European market, the Canadian Devices Conformity Assessment System (CMDCAS), and product safety testing services. Moreover, a variety of services is available through the global network of TÜV-SÜD Group.

TÜV-SÜD Group has continuously put a great deal of effort into improving the knowledge of its auditors globally by providing mandatory regular basic training, as well as the special training in certain fields corresponding to the expertise of each auditor. Auditors in TÜV-SÜD Japan Ltd. can provide strong support to our customers through audits and technical meetings based on the knowledge acquired through their abundant experience and training.

The third-party certification by the TÜV-SÜD Group is highly recognized as proof of the safety and high quality, not only in Japan but worldwide.

For details of each service, please click on a service from the index in the left column.