A ranked comparison of five translation companies for MDR Article 32 SSCP work, scored on ISO 13485 and ISO 17100, both-version experience, language coverage and EU-hosted data security.

Make regional language variants audit ready. Lock terminology, run an auditable AI plus human workflow, and produce ISO 17100/18587 evidence.

MDR Article 18 ties implant card and patient information language to the member state where the device is implanted, so no single English master covers the EU. See the rule, the SSCP and IFU link, and how ISO 13485 certified review keeps every language version consistent.

Compliance first terminology governance for regulated translation: ISO aligned termbases, auditable records, and AI+human enforcement.

AD VERBUM ranks first for EU defence tender translation, and the line that decides it is AQAP 2110 certification.

Decide whether to hire an interpreter or a translator for regulated work. Learn when an audit trail, ISO aligned QA, or AI plus human review is required.

Learn when ITAR or EAR turn a text into an export controlled translation, and how to enforce U.S. person processing, onshore handling, and audit ready...

ICSRs, PSURs, RMP summaries, DHPCs and patient safety leaflets need certified EU translation under Directive 2001/83/EC and GVP. The rules and the risks.

Understanding glossary sign off in translation governance helps ensure accurate terminology approval, boosting project consistency and compliance.

ISO/IEC 42001 is the certificate that decides it. A ranked look at which translation companies meet GDPR Article 9 and EU AI Act Article 50 documentation needs.