Medical translation: Difference between revisions

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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, pharmaceutical information, marketing or 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 and 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

Medical translation steps can include:

Extracting text from 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

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

References

External links

The Challenges of Selling in Multiple Markets

[1] "Resource Library for Medical Device Professionals".

[2] "EU Medical and IVD Device Labeling: Translation Requirements and Trends" (PDF).

[3] "Long live translation quality".

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[2]

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 {{Translation sidebar}}
-'''Medical translation''' is translating various types of documents, such as training materials for health care, medical device or pharmaceutical fields, marketing or clinical regulatory, and technical documentation. 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>{{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>
+'''Medical translation''' is the practice of translating various documents—training materials, medical bulletins, drug data sheets, etc.—for health care, medical devices, pharmaceutical information, marketing or 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 and 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 linguistic skills, medical translation requires specific training and subject matter knowledge because of the highly technical, sensitive, and regulated nature of medical texts.
-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.
 ==Process==
-Medical translation can be seen as a multi-step process. Steps in the process can include:
+Medical translation steps can include:
+* Extracting text from source format
+* [[Translation|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]
-*Extraction of text from source format
-*[[Translation]] – the conversion of the source language text to the target language text
-*Editing – reading and revision by a separate person to assure adherence to approved terminology and the proper style and voice.
-*Publishing – the translation is put back into the original format (e.g., Word document, Web page, e-learning program)
-*[[Proofreading]] – this ensures that the formatted translation displays correctly with no corrupted text, has proper punctuation and line and page breaks are correct.
-*In-country review – a native-speaking expert reviews the translation to ensure that it meets all specifications.
-Translation agencies can oversee both project management and linguistic aspects. [citation needed]
 ==Quality and Standards==
-Given the life and death nature of medical texts, there is 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=}}</ref>
+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=}}</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:
-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:
-*[[EN 15038]]&nbsp;– European standard for translation vendor quality ([[Translation-quality standards]])
+* [[EN 15038]] — European standard for translation vendor quality ([[Translation-quality standards]])
-*[[ISO 9001]]&nbsp;– quality system standard
+* [[ISO 9001]] — Quality system standard
-*[[ISO 13485]]&nbsp;– overarching standard for manufacture of medical devices
+* [[ISO 13485]] — Overarching standard for medical device manufacture
 ==See also==