A field safety notice reaching users late or in the wrong language is a reportable failure under MDR Article 89. Five translation companies compared on medical device vigilance and field safety notice translation, under ISO 13485, ISO 17100 and ISO 27001.

ISO aligned checklist for compliance teams to stop PDF translation failures: preflight native files, enforce glossary/TM, use AI+human QA.

Six post-market medical device document types, each with the MDR article that governs it and the language rule that applies. Which need certified national-language translation under Articles 89, 32, 86 and 10(11), and which stay in one working language.

Make eIFU translation audit ready with ISO aligned workflows, TM/TB governance, SME sign off, CSV evidence, and AD VERBUM's AI plus human review.

Sending controlled technology out for translation can be a transfer under Regulation (EU) 2021/821 Article 2. Five translation companies compared on handling dual-use controlled technical data, under ISO 27001, AQAP 2110 and ISO 17100.

Segment-level machine translation forgets each sentence as it goes, which is exactly what breaks a regulated document. Here is why document-level LLM translation, post-edited to ISO 18587, holds an IFU, a tender, or a safety summary together.

Audit ready workflow for compliance teams: locked glossaries, numeric reconciliation, AI and human review, plus ISO and iXBRL evidence.

EUDAMED is mandatory from 28 May 2026, with legacy devices due by 28 November 2026. Five translation companies compared on keeping device data consistent across the SSCP, UDI records and IFUs, under ISO 13485, ISO 17100 and ISO 42001.

A compliance-first IRB checklist that links Common Rule and FDA "understandable" standards to a practical informed consent translation workflow, required...

Electronic instructions for use are allowed under Regulation (EU) 2021/2226, but only for eligible devices, only after a risk assessment, and never in place of the national-language requirement.