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Quality Management

KARL STORZ has put in place a certified quality management system in accordance with the standards DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016. In addition, the system meets the requirements of the European Medical Devices Directive 93/42/EEC Annex II and additional national regulations and legal requirements, such as the Canadian Medical Device Regulation, the Japanese Pharmaceutical Affairs Law, and the QSR of the US FDA.

KARL STORZ is particularly committed to the safety of our instruments and devices. Testing product quality is therefore an essential part of our quality assurance measures. For this reason, we exclusively use components with proven reliability and safety. In close collaboration with accredited inspection offices, we perform detailed testing and obtain product certifications. The manufacturing and testing processes of our instruments and devices are reliable, efficient, and subject to continuous monitoring.

Each production process is followed by safety testing performed with specially developed testing systems, and the results are individually documented: This means that before delivery, each product leaves its distinctive fingerprint.