Our processes and risk analysis procedures are ISO 13485 certified to assure all translations are regulatory sound every time.
The translation of information for use in conjunction with a medical device requires highly specialized insight into the many regulations that govern it.
In addition to our exclusive focus on the life science industry, we have a team of highly specialized translation experts and linguists who are dedicated to managing the unique nuances of medical device projects including labeling, product manuals, patents and beyond. We know that patient safety, regulatory compliance, quality, scalability and price are top priorities. As a result, we have dedicated an entire section of our Quality Management System (QMS) to the translation of medical device content.
Our ISO 13485 certified translation processes, routine risk assessment procedures, technology solutions and intelligent use of translation memory ensure that clients receive the highest quality translations available.
Our trained translation experts develop customized solutions to specifically address each project’s requirements for a wide range of different document types for the medical device industry:
- Instructions for Use
- Operating Manuals
- Installation Manuals
- Regulatory Compliance Documents
- Software Applications
- Package Inserts and Labels
- Manufacturing Procedures
- Data sheets