The European Union (EU) has a comprehensive list of requirements for launching or marketing your medical devices in the 27 European countries. To read what’s changed – in detail – give our blog a read. Our services include: 1. Providing translations for all documents such as clinical trials, administrative records, and quality management system certificates required for regulatory assessments. 2. Implementing quick, accurate translations for documents like Instructions for Use (IFUs) which must be submitted before the CE (Conformité Européenne) marking that’s needed for conformity assessment. 3. Ensuring native-language translations for user manuals and product labels that the users can easily understand. 4. ISO 17100:2015 Certified and HIPAA Compliant translations to guarantee quality, precision and complete confidentiality.