We offer a comprehensive device service for all products manufactured by our company. This is focused on German legislation.
The focus of our offer is the implementation of legally required safety checks. The legislator determines the so-called level of protection that must be achieved by manufacturers and operators of medical devices. If electrotherapy devices are used as work equipment (e.g. by medical device consultants), parallel protection goals are binding, which come from medical device law and occupational health and safety law. The focus is on patient protection, the protection of third parties, the protection of users and the protection of employees.
The operator must set the deadlines for tests in accordance with DIN EN 62353, taking into account the generally accepted rules and in particular Appendix F of the standard. For safety checks (STK), deadlines should be set so that expected defects can be identified in good time. In Germany the tests must be carried out at least every two years, by the end of the month in which the medical device was put into service or the last safety check took place.
We offer specific recurrent tests for the medical devices produced by our company and use safety controls to ensure that the requirements of occupational health and safety as well as medical device law in Germany are essentially met.
We would be happy if you would like to know more about our device service.