Iso 13485 And Iso 14969 pdfs

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ISO 13485 - System of International Certification

ISO 13485:2003(E) vi © ISO 2003 — All rights reserved 0.3.2 Relationship with ISO/TR 14969 ISO/TR 14969 is a Technical Report intended to provide guidance for the ...

http://sic.com.ua/wp-content/uploads/2009/11/iso-13485-2003.pdf

Date added: August 18, 2016 - Views: 5

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13485-FDA Internal Audit Checklist -...

©2011 13485 Store GUIDELINES FOR USE OF THE CHECKLIST The checklist provides questions that refer to the ISO 13485: 2003 standard & US FDA requirements.

http://www.complianceonline.com/images/supportpages/10389/13F-Internal-Audit-Checklist.pdf

Date added: August 18, 2016 - Views: 8

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¿Qué es la ISO 13485? - nexfid.com

¿Qué es la ISO 13485? La industria de equipos médicos se ve afectada por toda una serie compleja de sistemas reguladores, normas nacionales e internacionales y ...

http://www.nexfid.com/pdf/Que_es_la_ISO13485.pdf

Date added: August 23, 2016 - Views: 1

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TÜRK STANDARDI - ISO 9001 Belgesi | ISO...

ICS 03.120.10; 11.040.01 TÜRK STANDARDI TS EN ISO 13485/Nisan 2004 İçindekiler 0 Giriş ...

http://www.iso-belgesi.net/wp-content/uploads/2013/01/TS-EN-ISO-13485.pdf

Date added: August 24, 2016 - Views: 1

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TABLE OF CONTENTS - Waters

This manual follows ANSI/ISO/ASQ Q9001:2008 and ISO 13485:2003 Quality Management Systems Requirements and uses ISO/IEC 90003:2004, Guidelines for the Application of ...

http://www.waters.com/webassets/other/corp/about/assets/files/wat000001qm.pdf

Date added: August 18, 2016 - Views: 1

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Setting the Medical Device Lifetime - Ombu...

Record Retention – ISO 13485:2003 . The record retention theme continues in this international standard. Clause 4.2.3 requires retention a copy of obsolete ...

http://www.ombuenterprises.com/LibraryPDFs/Setting_the_Medical_Device_Lifetime.pdf

Date added: August 18, 2016 - Views: 1

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Medical Device Quality Management System -...

Copyright 2012 ITRI 工業技術研究院 18 Medical Device Risk Management Risk Analysis •Intended use and identification of characteristics related to the safety ...

http://www.fda.gov.tw/upload/189/Content/2013011111445545705.pdf

Date added: August 18, 2016 - Views: 1

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Title: Guidelines for Regulatory Auditing of...

Guiddines for RegUlatory Auditing of Quality Managemeatt Systems ofbkdica 1 Device Manufacturers Part 2: Regulatory Auditing Strategy

http://www.fda.gov/ohrms/dockets/dockets/06d0011/06d-0011-gdl0001-Tab-11.pdf

Date added: August 18, 2016 - Views: 1

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Oversikt over standarder for Kvalitetsstyring

Side 5 Standarder for kvalitetsstyring Standardens nummer Tittel NS-EN ISO 9000:2005 Systemer for kvalitetsstyring - Grunntrekk og terminologi C, N

http://www.standard.no/Global/PDF/Kvalitet/Kvalitetsstyring%20februar%202009%20samlet%20web.pdf

Date added: August 18, 2016 - Views: 1