Medical and In-Vitro Device Services
The translation of information for use in conjunction with a medical or in-vitro 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 and in-vitro deviceprojects. This includes labeling, product manuals, patents and beyond.
We have dedicated an entire section of our Quality Management System (QMS) to the translation of medical and in-vitro device industries.
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:
|
|
|
|
|
|
|
|
|
Solutions for MDR & IVDR compliance
EU MDR and IVDR have posed a range of new challenges for MD and IVD manufactures in the way they create, manage, translate, submit, and deliver content and technical documentation in order to meet all requirements – including additional documentation that must be presented and translated in all 24 EU languages much earlier in the certification process.
RWS comprehensive services landscape has been carefully designed to guide our medical and in vitro device manufacturing partners through their regulatory journey with greater content control and oversight beyond translation, to ensure global compliance in all target markets.
Our Methodology
RWS is the leading provider of translation solutions for many international medical and in-vitro device companies. We have designed a number of internal standard operating procedures that dovetail with the requirements of European, Asian and U.S. regulatory bodies for varying document types containing medical and in-vitro device content. At a minimum, all translations go through a series of well-defined steps including a translation conducted by two highly qualified linguists, multilingual multimedia production, an additional quality control edit, final proofread, and certification.