How Can Medical Device Translations Improve Market Reach?
Medical device translations help ensure regulatory approval and effective patient communication for medical device companies launching devices across languages. The medical device sector part of the medical technology (MedTech) industry, focuses on medical products such as machines, devices, and apparatuses that treat, diagnose, and help prevent diseases. These devices can range from continuous glucose monitors, used every day by patients around the globe, to highly specialized imaging technology, medical software and IT, surgical instruments, and more. Because of the crucial function of many medical devices in promoting health, medical device translations are essential for reaching new patients and global markets.
Gaining the competitive advantage in a global industry currently valued at over 500 billion USD means that each step of a device’s lifecycle, from preclinical and clinical R&D and manufacturing to regulation and post-market oversight, requires detailed market-specific documentation.
To gain regulatory approval, compete in overseas markets, and ensure patient safety, medical device documentation such as instructions for use (IFU) and package labels and inserts must be translated accurately and with fast turnaround times. And as innovations in health solutions continue to arise, from medical wearables and software as a medical device (SaMD) to clinical decision support tools, medical device regulations become even more complicated. With a global network of 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 translations, medical software localization, and medical eLearning and training translations. CSOFT offers medical translation and localization solutions for a full range of medical devices, including:
- Implantable Medical Devices Translations
- Software as a Medical Device (SaMD) Translations
- Medical Wearables Translations
- Clinical Decision Support Translations
- Medical Device ComponentsTranslations
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) was replaced, and medical devices are now fully covered by the Medical Device Regulation (MDR). The MDR brings many new changes for manufacturers, including changes to medical device labelling and language requirements to gain EU MDR compliance. This has created new challenges for medical device manufacturers attempting to gain market access to EU’s diverse market. With all these new changes, it is important for medical device manufacturers to establish a partnership with a language service provider (LSP) that has an in-depth understanding of the new EU MDR and its implementation, to ensure there are no delays for medical device products entering EU’s market. With proven experience working with the medical device industry around the globe, CSOFT Health Sciences provides MDR regulatory translations to help companies meet the EU’s standards for bringing medical devices to market.
Learn more about our EU Medical Device Regulation (MDR) translations.
Medical Device Regulatory Translations
The medical device sector remains one of the most highly regulated industries within the life sciences, with strict laws and guidelines in place to protect patients, manufacturers, and all end-users of this technology. To navigate these regulations and successfully expand into new global markets, medical device regulatory translations for all required documentation are necessary and remain an effective solution for adhering to international medical and safety regulations. To help companies safely meet global standards for all phases of the product life cycle, CSOFT Health Sciences provides high quality life science regulatory translations in 250+ languages including medical device regulatory translations.
Learn more about our life science regulatory translations.
Software as a Medical Device (SaMD) Translations
In the medical field, software has a growing place in accelerating the ability to discover, manage, and treat all types of conditions, which makes Software as a Medical Device (SaMD) translations essential for integrating this technology into global medical markets. SaMD is any software that carries out medical functions without the need of actual hardware, and can help patients and healthcare providers in diagnosing and screening for disease, monitoring and alerting around chronic health conditions, disease and condition management, and digital therapeutics.
As a relatively new field within healthcare, SaMD plays a specific role in healthcare innovations, for example as the software used to control the motors of an infusion pump or the software that enables medical communications, including video calling, 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. To help companies safely and efficiently bring this technology overseas, CSOFT Health Sciences provides Software as a Medical Device (SaMD) translations in over 250 languages.
Learn more about our SaMD translations.
Medical Device Document Translations
The medical devices development process requires medical device manufacturers to submit a variety of medical device documents including documents for regulatory submissions, patents and international business agreements, instructions for use (IFU), manufacturing process descriptions, package labels and inserts, phase 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 in a timely manner. CSOFT Health Sciences specializes in end-to-end translations for medical device documentation across all stages of the medical device development lifecycle, and leverages a global team of over 10,000 linguists and subject matter experts to provide advanced medical translation of all document types.
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 safely and effectively develop new software products, therapies, or devices. 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. CSOFT Health Sciences specializes in high quality translations for medical software system guidance in over 250 languages.
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 the different components, operating systems, and mechanical features of these devices. Medical device manuals are technical documents that outline the procedures, instructions, protocols, and schematics pertaining to 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. Whether translating manuals to gain regulatory compliance or to educate staff and suppliers on operational procedures, CSOFT Health Sciences provides end-to-end medical device manual translations in 250+ languages.
Learn more about our medical device manual 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. 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 are able to monitor their health data and gather health metrics in real-time, which has opened 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 a minimum of 7 years’ in-field experience to ensure only the most accurate medical translation of your mobile medical app.
Learn more about our mobile medical application translations.
Medical Device Software Translation and Localization
Software is a core component of many medical devices, with such technology as x-rays, MRI and CT scans, and point of care in vitro diagnostics devices (IVD) transforming our ability to deliver precision care. Beyond the software in physical medical devices, in the past decade there has been a prominent type of medical device called Software as a Medical Device (SaMD). SaMD refers to software that performs medical functions itself, such as enabling patients to use their phones to look at MRI scans and patient portals that offer round-the-clock access to a patient’s health records. To gain regulatory compliance and stay competitive in overseas markets, medical device manufacturers must ensure accurate translation and localization of all software components. CSOFT Health Sciences has extensive experience in translating software GUI through our localization best practices. Our subject matter experts work closely with our in-country linguists and engineer teams to translate all medical device software applications for medical device companies across 250+ languages.
Learn more about our software localization services.
Translations for Medical Diagnostic Instruments and Implants
As the medical industry expands into novel markets and enterprises, and continues to generate inventive medical technologies, translations for medical diagnostic devices and implants are crucial. This ensures manufacturers, operators, and patients can safely produce, use, and integrate these innovative devices within the global market. These medical diagnostic devices, encompassing implants, are engineered to facilitate home-based medical tests, consequently saving the time and expenses linked to hospital visits. The variety of these devices, ranging from home-based EKG machines, blood pressure monitors, blood coagulation trackers, asthma monitors, to laser lancing devices, underscores the necessity for employing linguists who are not only skilled but also well-versed in the devices and associated regulations when localizing products for different international markets.
eLearning and Training Translations
Medical device manufacturers must ensure that proper training is offered to end-users such as patients, physicians, and other healthcare professionals on correct use of medical devices. In addition, medical device manufacturers need to train workers on how to correctly assemble and manufacture medical devices. 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. In addition, 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 to provide safe and high-quality services to clients. 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 safety of product use such as drugs, vaccines, biological medical products, medical devices, and radiation-emitting products. As companies and organizations continue to release products into new markets and reach customers throughout the world, keeping up with regulations and legislations is necessary to meet customer needs. CSOFT Health Sciences provides accurate translations for all types of regulations and legislations. With a global network of in-country linguists and expertise to translate over 250 languages, we localize your regulations and legislation content to ensure regulatory approval.
Learn more about our regulation and legislation translations.
Medical Wearables Translation
Medical wearables translations are essential for medical device companies launching wearable medical devices to patients around the world. Medical wearables are medical devices that are worn on a patient’s body to track vital signs to provide in-time monitoring of medical conditions and even notify patients and their healthcare teams about risks. Just as fitness trackers have taken over the commercial fitness world, wearable health technology and medical monitoring devices are expected to help revolutionize data tracking for healthcare workers and their patients. Medical wearables use advanced medical technology including ECG and blood pressure monitors, biosensors, and fall detection.
Whether medical wearables are used in decentralized clinical trials to monitor patient outcomes, to help patients recover after surgery and into rehabilitation programs, or to improve outcomes in hospitals, medical wearable translations ensure that these advances are accessible for every patient. From software localization and good manufacturing practice (GCP) to multilingual patents, our experts help companies advance health for the highest ROI. CSOFT Health Sciences’ global team of 10,000 in-country linguists, subject matter experts and software engineers is experienced in providing accurate and efficient translations for medical wearables and other medical devices.
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 a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time. 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 best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.