{"id":70723,"date":"2021-02-01T21:47:55","date_gmt":"2021-02-01T20:47:55","guid":{"rendered":"http:\/\/valtecne.com\/medical\/quality\/"},"modified":"2025-10-23T16:40:00","modified_gmt":"2025-10-23T14:40:00","slug":"quality","status":"publish","type":"page","link":"https:\/\/www.valtecne.com\/en\/medical\/quality\/","title":{"rendered":"Quality"},"content":{"rendered":"\t\t
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QUALITY CONTROL<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Certified quality procedures for medical devices industry<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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or<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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QUALITY SYSTEM<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Certified quality procedures in compliance to medical devices requirements<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Valtecne has always put a lot of effort into the implementation of its own quality system. Quoting from Valtecne\u2019s quality policy, \u201cthe success of the company and the satisfaction of the customers depend on the quality of supplied products<\/b>\u201d.<\/p>\n

The first quality certification ISO:9001 dates back to 1997. In the following years, after entering highly demanding markets such as medical devices, the company has furtherly implemented its quality system with sectoral certifications.<\/p>\n

Valtecne is certified in accordance with the UNI EN ISO 9001:2015<\/b>, and it is certified for the ISO 13485:2016 medical devices quality management system<\/b>. Furthermore, the facility is registered<\/b> in the Food and Drug Administration (FDA)<\/b>, confirming its commitment to the safety of its products.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tDownload ISO 9001 certification<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tDownload ISO 13485 certification<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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FDA
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Registered Facility
nr. 3027484613<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\"valtecne-2019-090\"<\/figure><\/a><\/div>
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CMM PRECISION CONTROL<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Quality control equipment<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The company has at its disposal a wide spectrum of quality control equipment.<\/p>

The most important assets are <\/span>three-dimensional measuring machines<\/b><\/span> (CMM \u2013 Coordinate Measuring Machine), mainly from Carl Zeiss AG. Valtecne\u2019s quality technicians do have the skills to program CMMs so that the probe measures what the drawing requires.<\/span><\/p>

Furthermore, the company is equipped with a complete set of precision control instruments such as altimeter, durometer, profilometer, calipers, gauges and so on.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\"Valtecne<\/figure><\/a><\/div>
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ISO 13485:2016<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Validation of processes<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Valtecne has carried out the validation of its own processes according to the international medical devices standard ISO 13485.<\/p>\n

The validation methodology is the one recommended by FDA, the American regulator, and it is based on three steps: IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification).<\/span><\/p>\n

The company has validated the following processes: machining<\/b>, passivation<\/b>, heat treatment<\/b>, polishing<\/b>, <\/b>welding<\/span>,<\/span> bead blasting<\/b>,<\/span> marking<\/b>,<\/span> <\/b>and <\/span>cleaning<\/span>.<\/span> Moreover, Valtecne has established a set of internal procedures and instructions to make sure that operating processes are compliant with the requirements established in the validation system.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

QUALITY CONTROL Certified quality procedures for medical devices industry Read more or Ask for informations QUALITY SYSTEM Certified quality procedures in compliance to medical devices requirements Valtecne has always put a lot of effort into the implementation of its own quality system. Quoting from Valtecne\u2019s quality policy, \u201cthe success of the company and the satisfaction […]<\/p>\n","protected":false},"author":2,"featured_media":70479,"parent":70705,"menu_order":6,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"class_list":["post-70723","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"\nCertified quality procedures for medical devices industry - Valtecne<\/title>\n<meta name=\"description\" content=\"Certified quality procedures in compliance to medical devices requirements: Valtecne is UNI EN ISO 9001: 2015 and ISO 13485: 2016 certified\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.valtecne.com\/en\/medical\/quality\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Certified quality procedures for medical devices industry - 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