The CEM/E²MS-enterprise TQ-Systems has been successfully audited by TÜV Süd (Technical Standards Organization South) in the field of medical devices and has been awarded DIN EN ISO 13485 certification. The german system service provider with its registered office in Seefeld near Munich develops and produces electronic components and complete devices for medical technology companies – from pocket-sized user terminals devices up to large clinical equipment. The certification serves in particular to inform enterprises who are not yet convinced by a concrete project of TQ’s high quality standards and the process reliability.

The consequences, if a device does not function or does not function properly, can be fatal in medical technology. “The certification of TQ in the field of medical technology means safety above all for our customers in medical technology and particularly for those interested parties. The certificate from an independent authority guarantees that TQ has fulfilled the high statutory demands on manufacturers of medical devices. Besides more and more medical technology enterprises demand the ISO 13485-certificate as a basic requirement from their business partners. We responded to this demand from the customers and carried out the complex and lengthy certification“, Detlef Schneider, Director of TQ, explained.

Quality management is of major importance to TQ, because TQ stands for “Technology in Quality“. TQ-Systems were certified in accordance with DIN EN ISO 9001 in the year of its establishment 1994. Successful recertifications in accordance with DIN EN ISO 9001 followed as well as certificates in accordance with DIN EN ISO 14001 (Environmental management), EN 9100 (civil aviation) and henceforth in accordance with DIN EN ISO 13485 (Medical technology).

The demands on the quality management system for manufacturers of medical devices are contained in the DIN EN ISO 13485. The standard is an internationally acknowledged standard and brings the high statutory requirements of medical technology in tune with the quality management system. The topmost target as also in the DIN EN ISO 9001 is the ongoing improvement of the quality of the product and services. In some points the DIN EN ISO 13485 goes beyond the DIN EN 9001 as in the case of recall or in risk management.