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A technical file is a set of documents tha … A technical file is a set of documents that describes a product and can prove that the product was designed in accordance with the requirements of a quality management system. All products that have a CE mark must have a technical file which must contain the information that proves that the product conforms with the EU directives and regulations for CE-marked products. EU enforcement authorities may demand a copy of the technical file for many years after the last product was made. Customers do not usually have access to the technical file.usually have access to the technical file.
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http://www.hse.gov.uk/work-equipment-machinery/technical-file.htm +
, http://www.conformance.co.uk/info/technicalfile.php +
, http://www.export.gov/cemark/eg_main_017275.asp +
, https://www.casim.de/leistungen/toleranzmanagement/ +
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http://dbpedia.org/resource/Category:Regulation_of_medical_devices +
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, http://dbpedia.org/resource/CE_marking +
, http://dbpedia.org/resource/EU +
, http://dbpedia.org/resource/Competent_authority +
, http://dbpedia.org/resource/ISO_13485 +
, http://dbpedia.org/resource/EU_medical_device_regulation +
, http://dbpedia.org/resource/Regulation_%28EU%29_2017/746 +
, http://dbpedia.org/resource/Technical_documentation +
, http://dbpedia.org/resource/Category:Quality_management +
, http://dbpedia.org/resource/Medical_device +
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http://dbpedia.org/resource/Category:Quality_management +
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rdfs:comment |
A technical file is a set of documents tha … A technical file is a set of documents that describes a product and can prove that the product was designed in accordance with the requirements of a quality management system. All products that have a CE mark must have a technical file which must contain the information that proves that the product conforms with the EU directives and regulations for CE-marked products. EU enforcement authorities may demand a copy of the technical file for many years after the last product was made. Customers do not usually have access to the technical file.usually have access to the technical file.
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rdfs:label |
Technical file
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