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

Trusted partner to 8 of the top 10 of the world’s leading med devices companies

ISO certified

Global presence to be where you need us

Minimum 99% on-time delivery, 99% translation accuracy, and 99% right first time

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.

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Our expertise covers:

Certified Translation IFUs with MDR/IVDR Compliance Content Authoring Regulatory Affairs

Certified Translation

Ensuring your audit success and regulatory compliance.

RWS is ISO13485:2016 certified, meaning we are specifically designed to meet the quality requirements for multilingual technical documentation aligned with the MDR/IVDR. Our processes are designed to identify, manage and mitigate risks associated with your submissions – of any risk classification, every step of the way.

IFUs with MDR/IVDR compliance

Saving you time and money

Before starting to globalize your technical content for your most critical product lines, we can verify that your master IFUs (Instructions for Use) are compliant with the MDR/IVDR and appropriate for all intended audiences. This IFU analysis gives you peace of mind and saves time and money as we check the master at the beginning of the process.

Content Authoring

How can localization turnaround and approval happen even more effectively when both time and quality are of the essence? By optimizing content at the source level to reduce development time, and plan for challenges in the road ahead, ensuring regulatory expertise is applied every step of the way. Our flexible services range from source validation to turnkey writing and editing, and our end-to-end solutions help clients create, translate, and deliver content to global teams.

Our content authoring solutions include:

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

An extension of your team, dedicated to navigating complex global regulations on your behalf

Today’s medical device companies aren’t just grappling with the complexities of designing, testing, and validating their products—they’re also tasked with ensuring the highest possible safety and quality standards for their devices. That means they’re subject to regulations that come with a full suite of strict requirements.

RWS stays at the cutting edge of research, to help prepare our clients for new regulations even before they go into effect. We offer specialized, ISO-certified services to ensure regulatory compliance and audit-ready technical documentation.

Solutions powered by tech

Content Authoring

Translation and Localization

Management of global submissions and approvals

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