ISO 13485
Certified since 2019Quality management for medical device translation
Our ISO 13485 certification supports translation workflows aligned with the expectations of medical device manufacturers, QARA teams and notified body audits.
Why it matters
ISO 13485 strengthens supplier control, risk-based thinking, documentation and traceability for translation processes connected to medical device compliance.
What it means for you
You work with a translation partner that applies stricter selection criteria for medical linguists than those required by ISO 17100 alone.