Regular training of our employees, the continuous monitoring of all processes, our strict quality management(QM) system, the exclusive use of approved materials as well as our in-process and final inspections ensure the high quality of each product delivered, and guarantees its reliability in use. Exact financial planning and cost management ensure that our customers can buy best products at favorable prices.
We implemented the extensive requirements as given under ISO 13485:2003 in all areas of our company. A QM system in accordance with ISO 9001 was first introduced at GEISTER in 1993. The transition to a QM system in accordance with ISO 13485:2003 took place in October 2005. At GEISTER Medizintechnik GmbH, the QM system applies for the following scope of medical products:"Design and development, production, distribution and repair service of surgical instruments and design and development, production and distribution of electrosurgical units (HF-surgical generators), HF-electrodes, HF-instruments, insufflators, suction/irrigation devices, bone saws, saw blades for bone saws, implants for bone surgery, distribution of sterile devices".
DIN EN ISO 13485:2003 is an independent standard, but with reference to DIN EN ISO 9001:2000. Its content largely exceeds DIN EN ISO 9001:2000 and includes additional specific requirements for medical devices, so that ISO 13485:2003 is much more extensive than the DIN EN ISO 9001:2000. The objective of ISO 13485:2003 is the fulfillment of legal requirements, the goal of ISO 9001:2000 is to improve the performance. Since October 2008, our recertification by TUV South Munich (notified body no. 0123) is exclusively made according to DIN EN ISO 13485:2003+AC:2007 and CMDR ISO13485:2003 (for Canadian CMDCAS). The certification status can be explored and viewed online on the TUV South website under
With the CE-marking (for class I products) and the CE0123-marking (for class sterile, IIA, IIB, III products) on our products we declare, that the marked products are in accordance with the EC directive MDD 93/42/EEC for medical devices. The EC-certificate and the associated CE mark is the basis for the free sale in the common market of the EC member states. In connection with the CE mark, we issue the declaration of conformity. In our own responsibility we declare and certify with this declaration, that the legal requieremnts and the state of the art are taken care of. Please note that surgical instruments of class I are by law not subject to the notified bodies audit and therefore cannot be listed in the attachment of the EC-certificate.
Our FDA registration number for deliveries into the United States is: 8010697. For products MDL-listed or 510K-approved in the United States, kindly refer to the corresponding website of the Food and Drud Administration under "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm" .
Due to special national registration and certification requirements in certain countries, some products might not be available for sale in those countries.
