Marketing materials are subject to firmer market surveillance requirements under the new EU MDR which requires CE marking for EU access. Medical devices are also subject to the EU Directive 2006/114/EC, concerning misleading and comparative advertising or Directive 2005/29/EC concerning unfair business-to-consumer commercial practices. This means that promotional content should be in perfect harmony with the technical documentation. Further, is also meant to be made available in the national language to earn the CE mark.
Translating marketing content requires strong linguistic abilities to ensure technical accuracy and fluency. To achieve compliance, we adopt a unique validation process involving client and sales reps input as well as terminology validation per the local market preferences. Our quality process involves:
- First translation and assessment of technical accuracy
- Fluency assessment and editing process
- External inputs from client (glossary) and sales reps (local preferences)