System certificates

KARL STORZ has a certified quality management system in place in accordance with standards DIN EN ISO 9001:2008 and DIN EN ISO 13485:2003. In addition, the system meets the requirements of EC directive 93/42/EWG concerning medical devices, Annex II, as well as several national guidelines and legal requirements, such as the Canadian Medical Device Regulation, the Japanese Pharmaceutical Affairs Law and the QSR of the US FDA.

The safety of instruments and equipment is a particular concern at KARL STORZ. We only use components that have been proven to be both reliable and safe. Testing product quality is another essential component of our quality assurance measures. Working in close collaboration with accredited test centers, detailed tests are performed, and product certifications are obtained. The manufacturing and testing processes of instruments and equipment are reliable, efficent, and subject to continuous monitoring.

At the end of every production run, safety tests are performed using specially developed automated test systems, and the test results are individually documented: this way, each product leaves its unique fingerprint before being dispatched.