Medical translation: Difference between revisions
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'''Medical translation''' is the translation of technical, regulatory, clinical or marketing documentation, software or training curriculum for the pharmaceutical, medical device or healthcare fields. Most countries around the world require that literature and labeling associated with medical devices or pharmaceuticals sold be translated into the national language(s). In addition, documents necessary to conduct clinical trials often require translation in order for local clinicians and patients and regulatory representatives to be able to read them. Regulatory approval submissions typically have to be translated as well.<ref>Regulations for Medical Devices and the Role of Guidance Documents in Europe [http://www.emergogroup.com/articles/how-europe-regulates-devices]</ref><ref>EU Medical and IVD Device Labeling: Translation Requirements and Trends [http://www.ce-mark.com/neweu.pdf]</ref> |
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'''Medical translation''' is the practice of [[Translation|translating]] various [[Document|documents]]—training materials, medical bulletins, drug data sheets, etc.—for health care, [[medical device]]s, marketing, or for clinical, regulatory, and technical documentation. Most countries require that companies and organizations translate literature and labeling for medical devices or [[Medication|pharmaceuticals]] into their national language. Documents for clinical trials often require translation for local [[Clinician|clinicians]], [[Patient|patients]], and regulatory representatives. Regulatory approval submissions typically must be translated.<ref>{{cite web|url=http://www.emergogroup.com/articles/how-europe-regulates-devices|title=Resource Library for Medical Device Professionals|publisher=}}</ref><ref>{{cite web|url=http://www.ce-mark.com/neweu.pdf|title=EU Medical and IVD Device Labeling: Translation Requirements and Trends |publisher=}}</ref> In addition to [[Linguistics|linguistic]] skills, medical translation requires specific training and subject matter knowledge because of the highly technical, sensitive, and regulated nature of medical texts. |
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Aside from linguistic skills, it requires specific training and subject matter knowledge in order to translate medical content. This is because of the highly technical, sensitive and regulated nature of medical texts. |
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==Process== |
==Process== |
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Medical translation steps can include: |
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Because medical translation is typically a multi-step process, it is usually carried out by a translation agency which oversees all project management and the linguistic team.{{cn|date=November 2014}} Steps in the process can include: |
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* Reviewing in-country by a native-speaking expert to ensure the translation meets all requirements |
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Translation agencies may oversee both project management and linguistic aspects.{{citation needed|date=April 2020}} |
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The life and death nature of medical texts mandates a strong emphasis on translation quality.<ref>{{cite web|url=http://blog.fxtrans.com/2009/11/quality-is-dead-long-live-measurable.html|title=Long live translation quality|publisher=|access-date=2010-05-04|archive-url=https://web.archive.org/web/20100110135511/http://blog.fxtrans.com/2009/11/quality-is-dead-long-live-measurable.html|archive-date=2010-01-10|url-status=dead}}</ref> The international medical industry is highly regulated, and companies who must translate documentation typically choose translation agencies certified or compliant with one or more of the following standards: |
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* [[ISO 13485]] — Overarching standard for medical device manufacture |
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Because of the high amounts of specificities, regulations, and challenges in the field of medical translation, some specialized translation companies have emerged who deal with medical translations exclusively. Some of these companies have hired medical practitioners to supervise the translation process.<ref>{{cite web|url=https://www.novimedgroup.com/blog-why-should-the-democrats-consider-a-specialized-translation-agency|title=Why should the Democrats consider a specialized translation agency?}}</ref> |
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==See also== |
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* [[Tremédica]] |
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• In-country review – a native-speaking expert reviews the translation to ensure that it meets all specifications and product or therapy specifics. |
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Given the life and death nature of medical texts, there is a strong emphasis on translation quality.<ref>[http://blog.fxtrans.com/2009/11/quality-is-dead-long-live-measurable.html Long live translation quality]</ref> |
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The international medical industry is highly regulated and companies who need to translate their documentation typically choose translation agencies that are certified or compliant with one or more of the following standards: |
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*[[ISO 13485]] – overarching standard for manufacture of medical devices |
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==References== |
==References== |
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==External links== |
==External links== |
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* [https://lingo.ae/4-practical-reasons-why-you-should-use-a-professional-translation-service/ 4 Practical Reasons to Use a Professional Translation Service] |
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* [http://www.medicaldesignonline.com/article.mvc/Going-Global-The-Challenges-of-Selling-in-Mul-0002 The Challenges of Selling in Multiple Markets] |
* [http://www.medicaldesignonline.com/article.mvc/Going-Global-The-Challenges-of-Selling-in-Mul-0002 The Challenges of Selling in Multiple Markets] |
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{{DEFAULTSORT:Medical Translation}} |
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[[Category:Translation]] |
[[Category:Translation]] |
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[[Category:Academic works about medicine]] |
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Latest revision as of 11:25, 3 September 2024
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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.[1][2] 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
[edit]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 and voice
- Publishing the translation in the original format (e.g., Word document, Web page, e-learning program)
- Proofreading to ensure the formatted translation has proper punctuation and line and page breaks, and displays correctly
- Reviewing in-country by a native-speaking expert to ensure the translation meets all requirements
Translation agencies may oversee both project management and linguistic aspects.[citation needed]
Quality and standards
[edit]The life and death nature of medical texts mandates a strong emphasis on translation quality.[3] The international medical industry is highly regulated, and companies who must translate documentation typically choose translation agencies certified or compliant with one or more of the following standards:
- EN 15038 — European standard for translation vendor quality (Translation-quality standards)
- ISO 9001 — Quality system standard
- ISO 13485 — Overarching standard for medical device manufacture
Because of the high amounts of specificities, regulations, and challenges in the field of medical translation, some specialized translation companies have emerged who deal with medical translations exclusively. Some of these companies have hired medical practitioners to supervise the translation process.[4]
See also
[edit]References
[edit]- ^ "Resource Library for Medical Device Professionals".
- ^ "EU Medical and IVD Device Labeling: Translation Requirements and Trends" (PDF).
- ^ "Long live translation quality". Archived from the original on 2010-01-10. Retrieved 2010-05-04.
- ^ "Why should the Democrats consider a specialized translation agency?".