Quality and safety at KARL STORZ

KARL STORZ focuses on the highest quality and safety. Our certified quality management system complies with the standards DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016 as well as international guidelines such as the EC Directive 93/42/EEC, the Canadian Medical Device Regulation, the Japanese Pharmaceutical Affairs Law and the QSR of the American FDA.

Product safety

The safety of our instruments and devices is our top priority. We only use tried and tested components and work closely with accredited test centers to carry out detailed tests and product certifications. Our manufacturing and testing processes are efficient and continuously monitored.
 

Individual safety tests

Each product undergoes rigorous safety tests with automated testing systems at the end of production. The results are documented individually so that each product leaves its own unique fingerprint.

Certificates