Medical Translation
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Medical Translation
Medical translation is the practice of translating various documents—training materials, medical bulletins, drug data sheets, etc.—for health care, medical devices, marketing, or for clinical, regulatory, and technical documentation. Most countries require that companies and organizations translate literature and labeling for medical devices or pharmaceuticals into their national language. Documents for clinical trials often require translation for local clinicians, patients, and regulatory representatives. Regulatory approval submissions typically must be translated. In addition to linguistic skills, medical translation requires specific training and subject matter knowledge because of the highly technical, sensitive, and regulated nature of medical texts. Process Medical translation steps can include: * Extracting text from the source format * Translating text to the target language * Editing by a separate person to assure adherence to approved terminology and proper style a ...
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Translation
Translation is the communication of the Meaning (linguistic), meaning of a #Source and target languages, source-language text by means of an Dynamic and formal equivalence, equivalent #Source and target languages, target-language text. The English language draws a terminology, terminological distinction (which does not exist in every language) between ''translating'' (a written text) and ''Language interpretation, interpreting'' (oral or Sign language, signed communication between users of different languages); under this distinction, translation can begin only after the appearance of writing within a language community. A translator always risks inadvertently introducing source-language words, grammar, or syntax into the target-language rendering. On the other hand, such "spill-overs" have sometimes imported useful source-language calques and loanwords that have enriched target languages. Translators, including early translators of sacred texts, have helped shape the very l ...
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Proofreading
Proofreading is the reading of a galley proof or an electronic copy of a publication to find and correct reproduction errors of text or art. Proofreading is the final step in the editorial cycle before publication. Professional Traditional method A "galley proof" (familiarly, "a proof") is a typeset version of copy or a manuscript document. It may contain typographical errors ("printer's errors"), as a result of human error during typesetting. Traditionally, a proofreader looks at an increment of text on the copy, compares it to the corresponding typeset increment, and then marks any errors (sometimes called "line edits") using standard proofreaders' marks. Unlike copy editing, the defining procedure of a proofreading service is to work directly with two sets of information at the same time. Proofs are then returned to the typesetter for correction. Correction-cycle proofs will typically have one descriptive term, such as "bounce", "bump", or "revise" unique to the departmen ...
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EN 15038
EN 15038 is a withdrawn quality standard developed especially for translation services providers. The EN 15038 standard ensured the consistent quality of the service. In 2015, CEN withdrew EN 15038 and adopted ISO 17100 as a European standard. Many European translation companies have long felt the need for a reliable method of demonstrating the quality of the services they provide to their customers. Many sought ISO 9001 certification as a demonstration of their commitment to quality management systems. However, as the ISO 9001 standard does not address the sort of translation-specific processes which many translators consider important in determining quality outcomes, this standard did not become widely accepted as a "guarantee of quality" in the industry. In 2006, a quality standard, specifically written for the translation industry, EN 15038, was published by CEN, the European Committee for Standardization. This was a serious attempt to provide certification of translation-spec ...
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Translation-quality Standards
Like any supplier of goods or services, a translator potentially bears ethical and legal obligations toward his patron or employer. This has turned to be of enormous importance with the development of the language industry at global scale. For the protection of both parties, standards have been developed that seek to spell out their mutual duties. History Standards of quality and documentation were originally developed for manufacturing businesses. Codes for all types of services are now maintained by standardization organizations such as the International Organization for Standardization. Standards of this type include those of the ISO 9000 series. As interest in quality management has grown, specific quality standards have been developed for translation services. These have included the Italian UNI 10574, the German DIN 2345, the Austrian Önorm D 1200 and Önorm D 1201, and the Canadian CAN CGSB 131.10. In 2015, EN 15038 was replaced by ISO 17100:2015. EN 15038 The E ...
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ISO 9001
The ISO 9000 family is a set of five quality management systems (QMS) standards that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. ISO 9002 is a model for quality assurance in production and installation. ISO 9003 for quality assurance in final inspection and test. ISO 9004 gives guidance on achieving sustained organizational success. Third-party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today. However, the ISO certification process has b ...
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ISO 13485
ISO 13485 ''Medical devices -- Quality management systems -- Requirements for regulatory purposes'' is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). The current ISO 13485 edition was published on 1 March 2016. Background Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task ...
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Tremédica
The International Association of Medical Translators and Writers and Related Sciences ( es, Asociación Internacional de Traductores y Redactores de Medicina y Ciencias Afines, acronym Tremédica) is an international organization devoted to the promotion of the professions related to medical translation.About TREMEDICA
Established in December 2005 in Washington, D.C. as a and currently registered in