Medical Device & In Vitro Diagnostic Translation and Technical Publication Solutions
Our global team of language, technology, and subject matter experts have the translation, localization, and regulatory experience medical device and in vitro diagnostic companies need.
With this winning combination, you can trust RWS to deliver your multilingual technical content quickly, correctly, and in compliance with required regulations such as MDR and IVDR.
Your Medical Devices strategy partner
The Content Challenge for Med Device and In Vitro Diagnostic Companies
Any business today faces pressure to create more content, for more markets and languages, at pace. For medical device and in vitro diagnostic companies, however, ever-changing regulations add yet another layer of complexity.
The journey a device takes, from product development through post-market surveillance, is long and complex, paved throughout with high content volumes and regulatory requirements in the form of MDR and IVDR. Today’s medical device companies need AI-powered ISO-13485 certified language partners with extensive industry experience, who can partner with them to navigate the complex world of content and regulations.
Our expertise covers:
Certified Translation
IFUs with MDR/IVDR compliance
Content Authoring
- Technical authoring and graphics development for IFUs and other document types
- Readability assessments, which are critical when producing documentation geared toward patients, such as plain language summaries and IFUs
- Native language checks when the source content is authored by nonnative speakers
- Technical editing reviews to ensure proper spelling, grammar, syntax, etc.
Regulatory Affairs
Solutions powered by tech
