design dossier/type examination dossier
Russian translation: досье дизайна/досье типа исследования
| 15:49 Oct 3, 2019 |
| English to Russian translations [PRO] Medical - Medical (general) / medical devices directive | |||||||
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|  Selected response from: harser Local time: 19:55 | ||||||
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| 4 | комплект конструкторской документации/ экспертиза типа медицинских изделий |
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| 3 | досье дизайна/досье типа исследования |
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Answers
3 hrs confidence: 
досье дизайна/досье типа исследования Explanation: - |
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23 hrs confidence:
комплект конструкторской документации/ экспертиза типа медицинских изделий Explanation: http://www.doks.nbog.eu/Doks/NBOG_BPG_2009_1.pdf the Medical Devices Directive 93/42/EEC section 4 of Annex II and section 4 of Annex III (design dossier related part of type-testing examination) http://www.icqc.eu/userfiles/File/directive 93 42 eec medica... 4. Экспертиза конструкции изделия 4.1 В дополнении к требования, предусмотренным в Разделе 3, изготовитель обязан подавать в нотифицированный орган заявку на проведение экспертизы конструкторской документации, относящейся к изделию, изготавливать которое он планирует, и которое относится к категории, упомянутой в Разделе 3.1. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSL... 4. Examination of the design of the product 4.1. In addition to the obligations imposed by Section 3, the manufacturer must lodge with the notified body an application for examination of the design dossier relating to the product which he plans to manufacture and which falls into the category referred to in Section 3.1. https://www.emergobyul.com/services/europe/technical-file-pr... https://www.curamedical.com/files/2018/08/CuraSpon-powder-EC... -------------------------------------------------- Note added at 23 hrs (2019-10-04 14:56:07 GMT) -------------------------------------------------- поправка .../ досье экспертизы типа... |
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