Quiet assemblies for regulated partners

SoftTrace, founded 2012 in Suzhou MedTech Park, operates 3,800 m² of ISO Class 7 and Class 8 cleanrooms with 95 staff—30 dedicated to QA/RA. Annual output: 4.5 million medical device components and assemblies for Class II and Class III applications across diagnostic, therapeutic, and surgical programs.

Certified to ISO 13485:2016 and FDA Registered (21 CFR 820), we publish how our ECO process flows—not only the certificate date. Biocompatible resin options listed by contact type, full lot-level traceability from resin batch to shipment, and sterilization validation support (EtO, gamma, autoclave) for OEM partners in over 20 countries.

We write calmly on purpose. Regulatory buyers trust process descriptions more than marketing superlatives — so our public pages describe clean-room classes, ECO gates, and documentation packs in plain English, then gate deeper SOPs behind a qualified RFQ.