Medical device translation exists in a highly regulated space. The EU Medical Device Regulation (MDR) requires that Instructions for Use be provided in the official language of every EU member state where a device is placed on the market. FDA labeling requirements have their own specifications. Translation of IFUs is not a checkbox exercise -- errors in device operation, cleaning, sterilization, or contraindication language can reach the clinicians or patients using the device.
We translate medical device documentation with translators who understand the regulatory framework the document is being translated for. EU MDR submissions get reviewers familiar with EUDAMED requirements, ISO 17664 for sterilization instructions, and IEC 62366 usability engineering conventions. FDA submissions get translators familiar with 21 CFR labeling requirements.
Device documentation types we regularly translate include: Instructions for Use (IFU) across all device classes; device labeling (primary packaging, secondary packaging, and labeling inserts); Technical Files and Design Dossiers for EU MDR submissions; Summary of Safety and Clinical Performance (SSCP) documents; Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) reports; and Declaration of Conformity documents.
For manufacturers managing multiple European markets, we offer coordinated multi-language projects that maintain terminology consistency across all target languages in the IFU package.
Medical device manufacturers, notified body consultants, and regulatory affairs teams managing EU MDR or FDA submission translation requirements.