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Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ...ply a CE mark under the Medical Device Directive, 93/ 42/ EEC, certification to ISO 13485 is required in most cases. This presentation is an in-depth analysis of ISO 13485 with comparisons to ISAO 9001. Areas Covered in the Session: * Principles of ISO 13485: 2003 * ISO 9001 & ISO 13485 Differences * Risk Management & ISO 14971 * FDA's MDR's & EU Vigilance * Design  more...
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tcw11--06/04/12-06:37:02-(462)[A]-[B]-[B]