In medical technology, quality isn't optional — it's a prerequisite. Erchinger manufactures to EN ISO 13485:2016, is an FDA-registered Contract Manufacturer, and fully documents every manufacturing step.
Quality in medical technology means more than a flawless end product — it means validated, reproducible processes, complete traceability, and documentation that stands up to scrutiny whenever approval is required. Erchinger meets these requirements through a quality management system certified to EN ISO 13485:2016 and FDA registration as a Contract Manufacturer.
"In medical technology, uncompromising quality is essential — that's why we rely on validated processes and complete traceability."
Certified processes, complete documentation and full traceability — the foundation of your trust as a customer.
All processes are validated to EN ISO 13485:2016 and are regularly audited and revalidated — for consistently reproducible quality.
Device History Records (DHR) are fully archived and available to you at all times — the foundation for your approval documentation.
Every manufacturing step of every instrument is traceable — from the material batch to final release.
Erchinger is certified to EN ISO 13485:2016 and registered as a Contract Manufacturer with the FDA (#9611827). All processes are regularly audited and revalidated as required.
EN ISO 13485 is the internationally recognised standard for quality management systems in medical technology. It sets requirements for the development, manufacturing and testing of medical devices and is a prerequisite for the approval of surgical instruments in many markets.
Device History Record (DHR) and Device Master Record (DMR) are manufacturing records that fully document every manufacturing and inspection step of an instrument. Erchinger maintains these records professionally and makes them available for your approval documentation as needed.
Erchinger provides all manufacturing- and quality-relevant documents and data sheets needed for the approval of your products — from technical documentation to DHR/DMR maintenance.
Request our documentation and certificates, or discuss your project directly with our team.
