• Regulatory Compliance
  We translate in accordance with EU MDR, FDA, and Health Canada standards
• Subject-Matter Experts (SMEs)
  All translations are completed and reviewed by linguists with medical and technical expertise
• Risk Reduction
  Avoid costly delays or product recalls due to inaccurate labeling or instruction for use (IFU) content

Process and Qualifications

• ISO 17100 and CGSB 131.10 certified (National Standard for Translation Services Canada)
• Expert standardised terminology management. Consistent, uniform terminology aligned with Heath Canada’s approved medical and regulatory vocabulary or other preferred terminology
• All labelling components (inner/outer labels, package inserts) are bilingual and identical in layout
• Clinical data summaries and administrative forms are translated if required
• Formatting (tables, dosage instructions, etc.) remains intact in the translation
• Use of medical translators, domain specialists with experience in all areas e.g. diagnostics, surgical tools, software as a medical device (SaMD).
• Linguists training aligned with MedDRA, SNOMED CT, and other medical taxonomies
• Creation of customized glossaries and style guides tailored to each manufacturer or device category
• Translation by native speaking medical professionals
• Multistep quality control, including back translation and terminology validation
• Multilingual DTP and formatting