Certification according to DIN ISO 13485
Every year we prove our ability and dedication to high quality. With the certification according to DIN ISO 13485 we meet the highest quality standards. Through a further certification according to Annex 2, we are also able to manufacture disposable products and implants that meet the CE marking standards.
An annual inspection guarantees a faultless quality management system and certifies the continuously high quality of our products. You can find the current certificate in our download area.
International certifications
USA: FDA Certification
As a supplier to large American companies, our products are also FDA certified and tested. Thus we prove our high quality standards also internationally and guarantee the customer the highest safety. Thanks to the high quality of the instruments, the risks of an operation on the patient are minimized.
Brazil: ANVISA
Recently our company has also been certified according to the regulations of the Brazilian authority for health surveillance ANVISA. After a process of registration that lasted over two years, we have completed the certification phase positively with the testing of our production. With this, we have once again proven our efforts and skills in terms of high product quality.
Other international certifications
In addition to the above mentioned certifications, we are registered in many other international countries and can therefore sell our products freely. For further information on international markets and quality standards, please do not hesitate to contact us.
