Company
ERCHINGER AG is a true Tuttlingen veteran company. Founded more than 70 years ago as a family business, we are now a company of the Swiss WISTAMA AG. This gives us a broad network with 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 realize and manufacture instruments for our customers in the fields of spine, proctology, and surgery. Our spectrum ranges from the technical implementation of standard instruments to highly complex, customer-specific solutions.
Quality
We guarantee complete traceability of all manufacturing steps. All records (Device History Record – DHR) are meticulously archived and are available to you at any time.
We support you in the approval of your products by providing all manufacturing and quality-relevant documents and data sheets.
We make the implementation of the Technical Documentation (Device Master Record – DMR) as efficient as possible for you.
We meet the highest quality standards. All processes are validated according to EN ISO 13485:2021 and are subject to continuous monitoring and demand-based revalidation. This is how we guarantee consistently reproducible quality at the highest level.
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 MANUFACTURING DOCUMENTATION
Professional management of Device History Records (DHR) and Device Master Record (DMR) based manufacturing records for maximum process reliability.

