The basis of certification (see basis of certification) is the international EN 13485 standard. The processes relevant for certification and related to the supply of medical devices and/or services associated with medical devices are subject to continuous surveillance.
This is one of the basic requirements for certification including the award of the TÜV SÜD certification mark. Certification always includes an on-site audit at the relevant sites. TÜV SÜD Product Service verifies that the certified organisation/organisation to be certified meets the requirements set forth in EN ISO 13485.
The requirements particularly concern design and development, production, installation and servicing and maintenance of medical devices.