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Medical Device Translations

We provide the highest quality translations and localization solutions to assist medical device companies as they expand into international markets

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Medical device translations are crucial in securing regulatory approval and facilitating effective communication with patients for companies launching devices across different languages. This sector, a vital component of the medical technology (MedTech) industry, is dedicated to medical products like machines, devices, and apparatuses designed for treating, diagnosing, and preventing diseases. The spectrum of these devices encompasses everyday tools like continuous glucose monitors used globally and highly specialized equipment such as imaging technology, medical software, IT solutions, surgical instruments, and more. Due to these devices’ pivotal role in promoting health, the necessity of medical device translations becomes evident for expanding reach to new patients and global markets. Securing a competitive edge in a global industry valued at over 500 billion USD entails meticulous attention to each phase of a device’s lifecycle. This involves comprehensive market-specific documentation from preclinical and clinical research and development through manufacturing, regulation, and post-market oversight. Attaining regulatory approval, competing effectively in international markets, and ensuring patient safety hinge on the accurate translation of medical device documentation. This includes crucial elements like instructions for use (IFU), package labels, and inserts, which necessitate precision and swift turnaround times. The landscape of medical device regulations becomes even more intricate as the industry witnesses ongoing innovations in health solutions. The complexity of complying with medical device regulations has escalated from the emergence of medical wearables and software categorized as a medical device (SaMD) to the advent of clinical decision support tools.

With a global network of over 10,000 in-country linguists and regulatory subject matter experts, CSOFT Health Sciences provides medical device companies with highly accurate and timely medical device translation services in 250+ languages, including all kinds of medical document translationsmedical software localization, and medical eLearning and training translations. CSOFT offers medical translation and localization solutions for a full range of medical devices, including:

EU MDR Translations

In May 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) were replaced, and medical devices are now entirely covered by the Medical Device Regulation (MDR). The MDR introduces various changes for manufacturers, including modifications to medical device labeling and language requirements essential for achieving EU MDR compliance. These alterations pose new challenges for medical device manufacturers aiming to secure market access in the EU’s diverse market. In light of these changes, it has become crucial for medical device manufacturers to establish a partnership with a language service provider (LSP) possessing a profound understanding of the new EU MDR and its implementation. This ensures the absence of delays for medical device products entering the EU market. Leveraging their proven experience collaborating with the medical device industry worldwide, CSOFT Health Sciences offers MDR regulatory translations, aiding companies in meeting the EU’s standards for introducing medical devices to the market.

Learn more about our EU Medical Device Regulation (MDR) translations.

Software as a Medical Device (SaMD) Translations

In the medical field, software plays an increasingly significant role in expediting the discovery, management, and treatment of various conditions. This underscores the necessity of Software as a Medical Device (SaMD) translation to integrate this technology seamlessly into global medical markets. SaMD refers to software capable of performing medical functions independently of physical hardware, aiding patients and healthcare providers in tasks such as diagnosing and screening for diseases, monitoring and alerting regarding chronic health conditions, managing diseases and conditions, and facilitating digital therapeutics. As a relatively new field within healthcare, SaMD plays a specific role in healthcare innovations, such as the software used to control the motors of an infusion pump or the software that enables medical communications, including video calls, scheduling appointments, and digital patient registration. More broadly, the applications of SaMD platforms include diagnosing and screening, monitoring and alerting, disease and condition management, and digital therapeutics. As SaMD platforms continue to advance, the global integration of this technology demands that the materials and content necessary for driving this growth be available in any language and tailored to the needs of any market.

Learn more about our SaMD translations.

Medical Device Document Translations

The medical devices development process requires manufacturers to submit a variety of medical device documents, including documents for regulatory submissions patents, and international business agreementsinstructions for use (IFU), manufacturing process descriptions, package labels and insertsphase 0-IV clinical trial documentation, post-market safety reporting, CE marking technical files, operation procedures, and more. As the demand for medical devices grows overseas, manufacturers must ensure that translations of each medical device’s documentation are completed accurately and promptly. CSOFT Health Sciences specializes in end-to-end translations for medical device documentation across all stages of the medical device development lifecycle.

Learn more about our medical document translation services.

Medical Software System Guidance Translations

Medical software system guidance translations are imperative to ensuring the success and regulatory compliance of medical software products and services in overseas markets. Product-specific guidance statements are issued by regulatory bodies such as the US Food and Drug Administration (FDA) and describe each agency’s current thinking on how to develop new software products, therapies, or devices safely and effectively. Medical software systems play a crucial role in healthcare today, and providing the correct documentation in the languages required for regulatory approval, including for Limited English Proficiency (LEP) patients in the US, and many languages in the EMA, NMPA, and more, is critical for patients and healthcare systems globally.

Learn more about our medical software system guidance translations.

Medical Device Manual Translations

Safely and properly operating medical devices to deliver precision care requires an in-depth understanding of these devices’ different components, operating systems, and mechanical features. Medical device manuals are technical documents that outline the procedures, instructions, protocols, and schematics for all types of medical devices. Especially when selling medical devices to international markets or training new staff on how to operate these devices, it is essential that all personnel fully understand the manual without language functioning as a barrier to communication.

Learn more about our medical device manual translations.

Mobile Medical Application Translations

As the medical devices and software markets grow, mobile medical application translations enable companies to expand their operations globally. Mobile applications are becoming an increasingly central feature in most industries, and the use of this technology in the medical field is opening new and innovative opportunities to improve health by accurately recording patient health data. Through mobile medical applications, patients can monitor their health data and gather health metrics in real time, opening the door to a growing demand for localizing these platforms and translating content. To help medical application developers tailor their technology to new patients across a wide range of languages, CSOFT Health Sciences provides end-to-end translations for mobile medical applications. Our linguists have at least seven years of in-field experience to ensure your mobile medical app’s most accurate medical translation.

Learn more about our mobile medical application translations.

Translations for Medical Diagnostic Instruments and Implants

As the medical industry expands into new markets and innovates with medical technologies, translations for medical diagnostic devices and implants play a crucial role. This ensures that manufacturers, operators, and patients can safely produce, use, and integrate these innovative devices into the global market. Engineered to facilitate home-based medical tests, these diagnostic devices, including implants, help save time and expenses associated with hospital visits. The range of these devices spans from home-based EKG machines, blood pressure monitors, blood coagulation trackers, and asthma monitors to laser lancing devices, emphasizing the need for linguists who are not only skilled but also well-versed in the devices and associated regulations when localizing products for different international markets.

Pharmaceuticals require expert translations

eLearning and Training Translations

Medical device manufacturers must ensure that proper training on the correct use of medical devices is offered to end-users such as patients, physicians, and other healthcare professionals. In addition, these manufacturers need to train workers to assemble and manufacture medical devices correctly. As the demand for medical devices grows overseas, providing highly accurate and culturally appropriate translated eLearning and training materials is essential for regulatory compliance and quality assurance. CSOFT Health Sciences provides eLearning and training translation and localization solutions to maximize product reach and ensure safe medical device operation across multiple markets. Additionally, CSOFT offers video translation services such as multilingual video voiceover, subtitling, and dubbing.

Learn more about our eLearning translations.

Regulation and Legislation Translations

Regulation and legislation translations are implemented to ensure compliance and provide safe and high-quality client services. Compliance has become more complex due to globalization, heightened expectations, innovation, and ever-evolving customer needs. Whether you are a pharmaceutical company, medical device company, or regulatory body such as the US Food and Drug Administration (FDA), International Organization for Standardization (ISO), or European Union (EU), regulations and legislations ensure the safety of product use such as drugs, vaccines, biological, medical products, medical devices, and radiation-emitting products. As companies and organizations release products into new markets and reach customers worldwide, keeping up with regulations and legislation is necessary to meet customer needs. CSOFT Health Sciences provides accurate translations for all types of regulations and legislation.

Learn more about our regulation and legislation translations.

Pharmaceuticals require expert translations

Medical Wearables Translation

Translations for medical wearables are crucial for medical device companies launching wearable medical devices worldwide. These devices, worn on a patient’s body, track vital signs, monitor medical conditions, and alert patients and healthcare teams about risks. Similar to how fitness trackers dominate the commercial fitness realm, wearable health technology and medical monitoring devices are poised to revolutionize data tracking for healthcare workers and their patients. Medical wearables incorporate advanced medical technology, including ECG and blood pressure monitors, biosensors, and fall detection. Whether employed in decentralized clinical trials for monitoring patient outcomes, aiding post-surgery recovery and rehabilitation programs, or enhancing outcomes in hospitals, medical wearable translations ensure accessibility to these advancements for every patient. Our experts specialize in software localization, good manufacturing practice (GCP), multilingual patents, and more, assisting companies in advancing health for the highest return on investment.

Learn more about our medical wearable translations.

Quality Assurance

CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards.  CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.

Learn more about our quality assurance process.

Data Security

With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.

Learn more about how CSOFT prioritizes data security.


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