Medical Device Labeling Translation

Medical devices must meet the essential requirements of the of the Medical Devices Directive before they can earn the CE mark and be exported and sold in the EU market. In particular, the information must be made available to the users and patients in their national language(s) regardless of the device use per Article 4(4) of the directive.

Labeling includes any operating instructions, warnings, or precautions to take for a safe use of the device. It also includes sofware UI, marketing information, and critical communications that affect the use of the medical device.

 
1

Risk Management
Content is analyzed for potential sources of errors: unclear source text, target audience, key terminology and reference materials are addressed at this pre-translation stage to avoid the costly errors that could affect the patient and user safety.

2

Quality Management
Our quality control process is backed by our strong qualifications and long experience in medical device translations. Specific QA activities include pretranslation steps, in process quality checks and final validation by in-country specialists.