Medical device translations
In our increasingly global economy, it is essential for the people in the medical device community to ensure that they are able to market and sell their products to as many people as possible regardless of cultural or language barriers.
Medical device translation services help companies in the life sciences industries to provide accurate, informative, and safety-ensuring materials to patients, caregivers, and healthcare professionals in all of their language markets and throughout the product life cycles.
Required Medical Certifications of LSPs
Before selecting a medical translation and localization vendor, a medical device company should make sure to check with the LSP to see if there compliant with ISO 13485:2003 which is an ISO standard that outlines specific quality management system requirements for companies providing medical devices and related services. ISO 13485:2003 also includes some of the requirements of ISO 9001:2008. An LSP needs to work according to the standard when they provide services to these types of businesses even though LSPs arent developing medical devices.
Translation Services in Medical Device Companies
Translation services have a gigantic impact in meeting the regulatory directives in different nations. In general, medical device documentation and labeling must be available in the official dialects of every country. Materials that require translation include the medical device labels, Instructions for Use (IFU), packaging, user interface (UI), marketing materials and other technical information. Medical device companies that sell their products worldwide may need to translate these materials in many different languages.
Accuracy and traceable processes are very important, especially for medical translations. An LSP should have defined quality standards, procedures, service levels, monitoring, security and continuous improvement processes. Medical device translation must meet strict industry standards in order to be accepted by regulators.
AML-Globals Expertise in Medical Device Translation
In order to achieve success internationally, a reliable and experienced translation company is required to navigate complex regulatory barriers and cultural differences. Accurate medical device translation is essential for documents such as instructions for use and software and user manuals.
AML-Global has over 30 years of medical devices translation expertise with projects completed for many of the world’s leading drug manufacturers and Medical Device manufacturing company. AML-Global is also ISO 9001 or 13485 certified, ensuring that all translated medical device content meets the regulatory requirements of the target language market by meeting translation quality assurance standards and regulatory compliance procedures.
American Language Services stands the test of time in providing voice over, translation, interpretation, transcription and media services to private industry, government at all levels, and educational and non-profit organizations. Our thousands of linguists around the world and teams of dedicated professionals are ready to serve.
Call Us Now: 1-800-951-5020 for further information or a quick quotation for your next project.
See more at: http://alsglobal.net/
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