Medical testing devices are designed to conduct medical tests in the comfort of a patients’ home, saving both time and money associated with an in-person hospital visit. A medical testing device can come in many forms, including blood coagulation monitors, home blood pressure monitors, asthma monitors, home EKG devices, and laser lancing devices.
An implant is a type of medical device that is implanted internally in the human body to reinforce or replace biological structures like organs and tissues, monitor bodily functions, and deliver drugs. Implants can be either permanent or temporary, and are constructed with a variety of materials, such as bioceramics, composites, polymers, and metals. A wide range of medical devices are considered implants, such as vascular grafts and pacemakers; retinal, neuronal, and cochlear implants; wound dressings and sutures; dental and spinal implants; insulin delivery devices, and cosmetic and structural implants.
As the demand for implants and medical devices grows globally, the need for highly-accurate translations of medical device documentation, clinical trial documentation, patient recruitment content, and eLearning solutions is vital to ensure regulatory compliance and market access. CSOFT’s global network of 10,000 linguists and subject matter experts provide timely and highly accurate medical testing device and implant documentation translation and localization in over 250 languages, helping you comply with regulatory guidelines and confidently expand into new markets.
Medical Device Documentation Translation
The medical devices development process requires medical testing device manufacturers and implants manufacturers to submit a variety of documents including regulatory compliance documentation for NMPA, FDA, and EMA submissions, legal documents such as patents and international business agreements, instructions for use (IFU), manufacturing process descriptions, package inserts and labels, and post-market safety reporting. As the demand for implants and medical testing devices shifts overseas, manufacturers must ensure that translation of the medical testing device’s and implant’s documentation is done accurately and in a timely manner. CSOFT Health Sciences specializes in end-to-end translation for medical device documentation across all stages of the medical device development lifecycle for medical testing devices and medical implant manufacturers.
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Clinical Trial Translations
Since some medical testing devices and implants are Class II or III medical devices, clinical trials are a requirement for obtaining market access. As the demand for implants and medical testing devices grows overseas, the need for highly accurate and timely translations and localizations of clinical outcome assessments (COAs), informed consent forms, patient enrollment forms, and patient recruitment and retention materials is vital to adhere to regulatory guidelines and enter local markets. CSOFT’s global network of 10,000+ in-country native linguists and subject matter experts (SMEs) have the linguistic and regulatory expertise and qualifications to help organizations achieve international compliance through highly-accurate clinical trial documentation translations.
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Implants are made from a variety of materials, including bioceramics, composites, polymers, and metals. To produce the materials to design implants such as knee, hip, and craniofacial replacements and spinal and dental implants, many different types of chemicals, plastics, and biomaterials are required. As the global chemical supply chain and manufacturing operations move overseas, there is a need for highly accurate chemical, plastic, and material manufacturing documents. CSOFT’s team of in-country native linguists and subject matter experts (SMEs) provide highly accurate and timely localizations of technical manual translations, testing software, eLearning courses, and more to help life science companies expand into new markets with confidence.
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We have well-documented and fully traceable information security policies, checklists, and quality records. CSOFT understands the importance of security to our clients and we take nothing for granted when confidentiality is a concern. All our data and security processes comply with our certified ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001.
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High-quality Class I, Class II, and Class II medical device translations is extremely important the life science, which are highly complex devices that require precise instructions to operate effectively. Inaccurate translation along the way can not only result in wasted time, money, and effort, but also negatively affect patients’ lives. That is why CSOFT is dedicated to ensuring the highest-quality medical device solutions for the life science . In order 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. In addition, we have perfected our localization best practices through linguistic validation, back translation, terminology management, and in-country review (ICR). We have the tools and team to help you meet the submission demands of regulatory bodies such as the FDA, EMA, and NMPA.
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