What’s inside the checklist
25 audit items across 5 compliance areas — built on EU MDR 2017/745 Article 10 and ISO 17100.
✓ Used by EU MDR compliance teams at medical device manufacturers
✓ Based on EU MDR 2017/745 Article 10 and ISO 17100 requirements
✓ Covers all 5 critical compliance areas — language coverage to EUDAMED registration
Language Coverage Audit
Map every device to every EU market. Identify exactly which languages are required and which IFU translations are missing.
Translation Quality Requirements
Verify ISO 17100 compliance, SME reviewer qualifications, In-Country Review documentation, and terminology management.
IFU Document Version Control
Detect version mismatches between source and translated IFUs — the most common audit finding in technical file reviews.
EUDAMED Registration Alignment
Confirm IFU document references in EUDAMED match your QMS-controlled versions. Assign update ownership.
Pre-Deadline Timeline Planning
A week-by-week compliance timeline from today to May 26, 2026. Know exactly when you need to start to finish on time.
Trusted by medical device and engineering manufacturers worldwide
Link Translation has delivered ISO 17100-compliant IFU translations and technical documentation for manufacturers including Boston Scientific, Volvo, Intel, and Caterpillar, across EN↔PT-BR and EN↔ES-LatAm language pairs, for over 15 years.
