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