Medical Device File

Russian translation: досье медицинского изделия

07:09 Aug 2, 2019

English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals / Quality Assurance

English term or phrase: Medical Device File

4.2.3 Medical Device File
For each finished medical device type or family manufactured by Alcon Ireland, files are established and maintained which contain or reference documents generated to demonstrate conformity to the requirements and compliance with applicable regulatory requirements.

Olesya Poleschuk KudoZ activity Questions: 156 (1 open) (15 closed without grading) Answers: 2 Kazakhstan
Local time: 13:51

Russian translation:досье медицинского изделия

Explanation:
Я бы сказала, что file - это "досье", по аналогии с Product File или Site Master File.
Можете посмотреть вот эту ссылку и сверить по контексту, подходит ли вам такое определение: Классификатор видов документов регистрационного досье медицинского изделия http://docs.cntd.ru/document/557054059

Можно выбрать и более общий термин: "документация на медицинское изделие"
В любом случае file - это комплект документов.

Selected response from:

Oksana Liash
Ukraine
Local time: 09:51

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досье медицинского изделия

Oksana Liash

Summary of reference entries provided

José Patrício

Answers

2 hrs confidence:

peer agreement (net): +2

medical device file

досье медицинского изделия

Oksana Liash
Ukraine
Local time: 09:51
Works in field
Native speaker of:

Russian
PRO pts in category: 8

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Reference comments

1 hr

Reference

Reference information:
These together can be called device special files in contrast to named pipes, which are not connected to a device but are not ordinary files either. - https://en.wikipedia.org/wiki/Device_file
In Unix-like operating systems, a device file or special file is an interface to a device driver that appears in a file system as if it were an ordinary file. - the same link
In computing, a file system or filesystem (often abbreviated to fs), controls how data is stored and retrieved. - https://en.wikipedia.org/wiki/File_system
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In computing, a device driver is a computer program that operates or controls a particular type of device that is attached to a computer.[1] A driver provides a software interface to hardware devices, enabling operating systems and other computer programs to access hardware functions without needing to know precise details about the hardware being used. - https://en.wikipedia.org/wiki/Device_driver

José Patrício
Portugal
Native speaker of:

Portuguese

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Medical Device File

Russian translation: досье медицинского изделия

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