Company
The ERCHINGER AG is a typic Tuttlingen veteran company. Founded more than 70 years ago as a family business, we belong now as a German branch to the Swiss WISTAMA AG. Consequently, we are part of Group’s network and thus the ERCHINGER AG benefits in their technical processes by being granted full interco access to the latest technologies.
Our core of around 30 employees are regularly trained and highly qualified. Experienced technicians, CNC specialists and surgical mechanics are the basis for a guaranteed top-notch quality which earned us domestic and international recognition and appreciation.
Due to our lean hierarchy, we are flexible and responsive. Our appreciative cooperation ensures high motivation and willingness to perform in the entire team.
We design, develop and manufacture surgical instruments for our customers in the fields of spine, proctology and surgery. Our spectrum ranges from standard instruments to highly sophisticated, complex and customer-specific instruments.
Quality
We guarantee complete traceability at all stages of our production processes. All records (Device History Record DHR) are meticulously archived and can be made available at any time.
We can support you with regulatory matters by providing production- and quality-related documents and respective data sheets.
The technical documentation (Device Master Record DMR) is made very easily available and accessible to all of our customers.
We meet the highest quality standards. All processes are validated according to EN ISO 13485:2016 and are regularly revalidated. In this way we can guarantee reproducible quality.
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