Life Sciences + Health

Leaders in Medical Translation in 250+ Languages

Linguistic Validation

Effective linguistic validation services are essential to ensuring the quality and validity of translated clinical outcome assessments (COAs), as well as multilingual clinical trials. Learn how CSOFT’s team of medical linguists and subject matter experts like doctors, clinicians, and healthcare professionals are dedicated to delivering the highest-quality linguistic validation services for the best possible ROI.

The EU MDR Labelling Journey: Best Practices for Navigating the Latest Medical Device Labelling Requirements

Our most recent white paper provides an overview of the EU MDR 2017/745’s noteworthy changes and important dates for compliance; specific labelling requirements for medical device product labels, implant cards, IFU and eIFUs, and Unique Device Identifiers (UDI); and specific ways CSOFT’s harmonized translation process and labeling engineering expertise can ensure EU MDR labelling compliance for medical device companies.

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.

In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746: Five key questions answered for MedTech Companies

With the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 set to be implemented on May 26, 2022, medical device companies looking to market their products in the EEA must adapt their regulatory submission and processes to comply with the new regulation. Our most recent blog post answers 5 key questions for MedTech companies expanding into the diverse market.

FDA Approves Chiesi Global Rare Diseases’ Ferriprox for Sickle Cell Disease

The U.S. Food and Drug Administration (FDA) approved Chiesi Global Rare Diseases’ Ferriprox for treating transfusional iron overload which is caused by sickle cell disease (SCD).

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

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    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.

    NMPA Approves PARP Inhibitor Pamiparib of BeiGene
    NMPA Approves PARP Inhibitor Pamiparib of BeiGene

    China's regulatory body, the National Medical Products Administration (NMPA), has granted conditional approval to BeiGene's PARP inhibitor pamiparib for treatment of patients advanced ovarian cancer. The approval marks the first for pamiparib and the third for...