Quality – assembled in Tuttlingen
Our assembly
Our qualified surgical mechanics, some of whom have decades of experience, assemble the surgical instruments professionally and with the highest standards of precision and quality. We attach particular importance to ensuring the quality and functionality of each individual instrument and carefully checking them according to customer specifications.
We assure 100% functionality of each manufactured and supplied surgical instruments.
WE STAND FOR
Quality
All processes are validated according to EN ISO 13485:2016 and are regularly revalidated.
Certification
We are FDA registered as a contract manufacturer (#9611827) and EN ISO 13485:2016 certified.
TECHNICAL DOCUMENTATION
Use of Device History Record DHR (manufacturing records) and Device Master Record DMR