Medical Software System Guidance Translations

CSOFT Health Sciences provides medical software system guidance translations to help ensure that medical software manufacturers can develop innovative technology for any market.

Contact us now
Home 9 Medical Software System Guidance Translations

Medical software system guidance translations are imperative to ensuring the success of medical software products and services in overseas markets. Product-specific guidances are published by the US Food and Drug Administration (FDA) and describe the Agency’s expectations and current thinking on how to safely and effectively develop new medical products. To reach patients globally, submitting the correct documentation for regulatory approval and meeting certain language requirements is an important part of the development cycle for medical software systems. From hospitals to medical device manufacturers, delivering high quality medical software translations and medical software system guidance translations that leverage the best practices of localization and technological expertise is central to success.

In addition to our medical software system guidance translations, our global network of in-country linguists and subject matter experts provide translations for other government issued guidances, including pharmaceutical product guidance translations.

Learn more about our pharmaceutical product guidance translations.

Medical Software Localization

Medical software continues to play a critical role in global healthcare systems with important applications that range from data storage to patient communications. Medical software localization, including medical software system guidance translation, is central in bringing this technology to new markets and fostering cross-border communication in the life sciences industry. CSOFT Health Sciences provides end-to-end medical software localization and translation solutions that include software GUI translations, DevOps continuous translations, and point of care IVD software translations.

With a global network of 10,000+ linguists and subject matter experts, we have experience in all types of medical software localization, including mobile medical app translations, patient portal translations, software as a medical device (SaMD) translations, and medical website translations

Learn more about our medical software localization.

Regulatory Translations for Medical Software System Guidance

The regulatory process for medical software systems consists of strict regulations for a full range of documentation and data, including language requirements. Medical regulatory translations for global regulatory compliance might include Instructions for Use (IFU) translations, Informed Consent Form (ICF) translations, IRB correspondence translations, and more. CSOFT Health Sciences specializes in regulatory translations for medical software systems and medical devices.

Learn more about our medical regulatory translations.

Mobile Medical Application Translations

As the medical devices and medical software markets continue to grow, mobile medical application translations enable companies to expand their operations globally and reach new markets. In today’s digitized medical space, mobile applications are becoming an increasingly popular and efficient solution for collecting patient data and improving ones’ health. To help medical companies reach new markets and adapt their technology to new customers, CSOFT Health Sciences provides end-to-end translations for mobile medical applications, reaching customers in 250+ languages.


Learn more about our mobile medical application translations.

A.I. Translations
ISO-certified Academic Translations

Data Security

CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data and security processes are certified with ISO 13485:2016, ISO 9001:2015, and  ISO 17100:2015, and leverage best practices from ISO 27001.

Learn more about how CSOFT protects companies’ data.

Quality Assurance

High-quality translation is extremely important in the life sciences, and inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance specific to the life sciences, which includes linguistic validation, to ensure that any project meets quality standards in a timely and cost effective manner. To do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts and advanced language technology. In addition, we have perfected our localization best practices through back translation and terminology management to help you reach patients globally, in over 250 languages. To further ensure the highest-quality technical translation solutions, CSOFT’s proven expertise is backed by our ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified quality management system.

Learn more about our quality assurance process.

High Quality Academic Translations


Speak to one of our support agents.