IT EN BR RESERVED AREA PRODUCTS INNOVATION COMPANY NEWS CONTACTS HOME / NEWS / RECENT ACHIEVEMENT FOR THE TTR OPERATING ROOM LINE NEWS 22 September 2016 RECENT ACHIEVEMENT FOR THE TTR OPERATING ROOM LINE ISO 13485 is a quality management system standard specific to companies in the medical sector, which includes aspects of the ISO 9001 standard and specific requirements for the medical device sector. EN ISO 13485: 2012 has been harmonized in consideration of the three European Directives on Devices (Medical Devices, In Vitro Diagnostic Medical Devices and Active Implantable Medical Devices), certification in accordance with this standard by an accredited certification body assumes the compliance with the specific clauses present in these three directives. NEWS-ARCHIVE 2016 2015 2014 2012 COMPANY Via E. Papini, 19 - 43036 Fidenza (PR) - Italy Tel. +39 0524 533417 info@pluritex.it Download the brochure RESERVED AREA Login Sign in Password recovery OUR PARTNERS MANAGEMENT SYSTEM CERTIFICATE © Pluritex srl 2014 VAT number 01549540332 CreditsLegalPrivacyTerms of sale Our website uses cookies. Read the information to find out more. By continuing to browse, you accept the use of cookies. Ok