Class I, Class II, and Class III Medical Device Translation and Localization
Helping Class I, Class II, and Class III medical device manufacturers and companies expand into international markets with confidence
Medical devices are separated into three different classes based on the amount of regulation the device needs given the danger it poses to the consumer. In Europe, two additional sub-classes are added: Class IIa medical devices and Class IIb medical devices.
Class I medical devices pose the lowest risk to consumers and include nonelectric wheelchairs, bandages, handheld surgical instruments, personal protection kit, stethoscopes, corrective glasses, and more. Class II medical devices are considered to pose an intermediate risk, and can include infusion pumps for intravenous medications, computed tomography (CT) scanners, and powered wheelchairs. Class III devices are viewed as being the highest risk for consumers and include devices like breast implants, pacemakers, HIV test kits, cochlear implants, and defibrillators. The medical device’s classification determines the device’s regulatory requirements to obtain marketing approval.
As the demand for Class I, Class II, and Class III medical devices grows worldwide, the need for highly accurate translations of medical device documentation, clinical trial documentation, patient recruitment content, and eLearning solutions is critical to ensure regulatory compliance and market access. CSOFT’s global network of 10,000+ linguists and subject matter experts provide multilingual translation solutions for Class I, II, and III medical devices to help life science companies expand into new markets with confidence.
Medical Device Documentation Translation
The medical devices development process requires Class I, Class II, and Class III medical device manufacturers to submit a variety of documents, including regulatory compliance documentation like 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 medical devices shifts overseas, manufacturers must ensure that translation of each class of medical device’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 all classes of medical devices.
Learn more about our medical device document translation services.
Clinical Trial Translations
For Class II and Class III medical devices, clinical trials are a requirement for obtaining market access. As the demand for Class II and III medical 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 penetrate the 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.
Learn more about our clinical trial translation solutions.
Medical device manufacturers must ensure that proper training is offered to end-users such as consumers, doctors, and other healthcare professionals on correct use of Class II and III 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 materials is essential for regulatory compliance and quality assurance. CSOFT provides eLearning 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 translation services.
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.
Learn more about our data security.
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.
Learn more about our quality assurance process.