Life Sciences + Health

Communication Solutions into 250+ Languages for a Healthier World

Medical Device Translation

We provide the highest-quality medical device translation services for life science companies expanding into global markets, from in vitro diagnostic devices and SaMD to Class I, Class II, and Class III medical devices.

Translating TMFs for Global Clinical Trials

TMFs/eTMFs hold crucial clinical technical documentation that demonstrates the study is being conducted following Good Clinical Practices (GCP) guidance. For global clinical trials, TMF translation is a necessity for gaining local regulatory approval.

Medical Device Market Overview and Regulatory Landscape in Asia

In our latest white paper, the Asian medical device market’s landscape and regulatory overview is discussed, with focus on seven major players (China, Japan, Korea, Malaysia, Australia, Thailand and India) and the critical role that language service providers play in the APAC region.

FDA Approves First Ever 3D-Printed Bone Replacement

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has granted approval for the first customized 3D-printed bone replacement.

Are you looking for an industry outside of the Life Sciences?

We are dedicated to industry-standard knowledge and quality

Helping You Globalize the Right Way

CSOFT’s experienced and dedicated global regulatory submission specialists help companies comply with these demanding multilingual documentation requirements for submissions while providing the highest linguistic quality

We can help you attain the appropriate, accurate, and sustainable compliance required throughout the entire submission process. We ensure our clients receive the necessary certifications to successfully enter emerging markets.

Medical Translation with a Focus on Precision

Our translation solutions are intended for document types relating to every stage of product development life cycle.

Quality in translation is extremely important, but within the life sciences industry, incorrect translations could literally be life threatening. We use industry-standard processes, however, we also offer flexibility for each customer to allow for their companies’ success, no matter the process.

 

Industries We Serve

Who We Are

CSOFT Health Sciences provides end-to-end medical translations for all phases of the product lifecycle, from pre-clinical to post-launch. We also specialize in market access consulting, medical writing, and CTD/eCTD submissions with the FDA, EMA, and NMPA.

Our operations are compliant with ISO 17100 and certified in ISO 9001:2015 and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of global submissions.

The Power of Linguistic Expertise

Right Tools. Right Resources

Tools we use

We use a full range of CAT tools including Trados, MemoQ, Transifex, Smartling, and WordServer and translate all document types, including .ai, .doc, .pdf, .ppt, .xlx, .css, .php, .html, .xml, .mml, .txt, .mpg, .mov, .zip, .psd, and more.

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Linguists we hire

Our native in-country subject-matter experts with at least 7 years’ experience go through a rigorous certification process and are guided with customer experience surveys

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Methodologies we employ

We employ a full range of customized solutions, including translation memory, glossary and style guides, PLLP, and more.

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Start Your Global Journey

Headquarters

501 Boylston Street, 10th Floor
Boston, MA 02116

Phone

The Knowledge Vault

Stay in the know

For many years, CSOFT has been supporting the life science industries as they continue to grow. We are dedicated to providing the highest-quality services to our clients, while making sure they have access to different policies and up-to-date information. As a medical communications company, we are taking the initiative to promote and increase awareness in the science community and to every individual.

FDA Makes Recommendations for COVID-19 Variants

The U.S. Food and Drug Administration (FDA) has revealed recommendations for drug developers and diagnostic test makers to address the efficacy and overall performance of their products in consideration of the COVID-19 variants. The updates in recommendations are...

FDA Approves First Ever 3D-Printed Bone Replacement

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has granted approval for the first customized 3D-printed bone replacement. The device, named Patient Specific Talus Spacer, is the only 3D-printed device in the world, and...