Patient consent form translation and ongoing clinical communication program
Summit Valley Health Network had a growing non-English-speaking patient population -- primarily Spanish, Russian, and Arabic -- and was using a mix of ad-hoc staff interpreters and online translation tools to handle informed consent forms. Two incidents involving consent documentation had flagged translation accuracy as a risk area in their compliance review.
We audited the existing consent form library (38 documents) and re-translated the complete set across all three language pairs, assigning specialist translators with healthcare background to each pair. A standardized glossary was built for each language pair to ensure consistency across all forms. We set up an ongoing service agreement for new form additions.
All 38 forms retranslated and approved by their legal compliance team within 6 weeks. Ongoing additions now have a 48-hour SLA. No translation-related compliance flags in the 18 months since.
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EU MDR regulatory submission -- full IFU package translation
MedInnovate was preparing a EU MDR submission for an electrosurgical device system and needed German and French translations of a 14,000-word Instructions for Use package, including technical specifications, warnings, contraindications, and cleaning procedures. The package had to meet ISO 17664 and IEC 62366 formatting conventions.
We assigned senior technical translators with medical device regulatory experience in both target languages. A regulatory terminology review was conducted before translation began to ensure EU MDR-compliant language for warnings and contraindication sections. Formatting was matched to the source document specification.
Regulatory submission accepted at first review. No linguistic queries raised by the notified body. The IFU translation was specifically noted as clean in the review documentation.
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