When the words on paper guide real medical actions — there’s no room for “probably close.”
We translate safety-critical content like it will be used in surgery, dosing, or diagnostics. Because it often is.
What Makes These Documents So High-Stakes?
Medical safety documentation isn’t supporting content.
It’s core to patient outcomes and clinical accountability.
We routinely work with:
✅ IFUs for Class II and III devices
✅ Warning labels and safety notices in multiple jurisdictions
✅ Dosage sheets where units and terms must be flawless
✅ Clinical trial protocols and investigator brochures
✅ Instructions for sterilization and reprocessing
One term out of place, and you risk regulatory rejection, legal exposure, or patient harm.
Built for Risk-Averse Environments
We handle these texts like you handle your device builds — with layers of control.
✅ Dual-linguist translation + senior review
✅ ISO 17100 process with traceable QA
✅ Use of client-approved terminology only
✅ Layout checks to catch unit shifts or truncations
✅ Side-by-side source/target validation
It’s not proofreading. It’s safety assurance.
Terminology That Stands Up to Scrutiny
We never guess. We verify. And where terms matter most, we escalate.
✅ Custom termbases built with your regulatory, legal, or clinical teams
✅ Jurisdiction-specific variants (e.g. “contraindications” vs. “adverse reactions”)
✅ Consistency across documents and product lines
✅ Full revision history for every term change or override
We’ve seen how “just translating it” goes wrong. We’re here to prevent that.
When Layout Breaks Safety, We Catch It
Formatting errors are easy to miss — until they’re submitted.
We run full pre-submission checks on:
✅ Overflows in multilingual PDFs
✅ Lost measurement units in CAD exports
✅ Broken formatting in dosage tables
✅ Mislabeled language headers
✅ Inconsistent numbering or symbol placement
What looks fine in Word can break compliance in a second.
Mini-Case: The Missing Microliter
“A single μL unit was dropped from a dosage chart in the German IFU. No one saw it — until QA flagged it on final pass. That catch avoided a likely Class II recall.”
— QA Lead, Global Diagnostics Company
We Speak Audit
When notified bodies come knocking, our files hold up.
✅ ISO 17100 certificate?
✅ Audit trails for each revision?
✅ NDAs on file?
✅ HIPAA & GDPR compliance?
✅ Format requests for FDA, EMA, MHRA?
✅ Translator credentials? Attached.
We’ve sat in enough audits to know what’s checked — and what fails fast.
Engagement Models That Fit Clinical Workflows
✅ Project-based or ongoing engagement
✅ Secure portal for file uploads and reviews
✅ Collaborative review cycles with your regulatory or clinical teams
✅ Emergency turnarounds (24–48h) for redline updates
✅ Flat-rate or per-page pricing depending on document type
You’re not just translating. You’re preparing for inspection, use, and risk mitigation.
Medical safety content isn’t just information. It’s instruction.
We treat every word like it might be used to keep someone breathing.
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