Registration number (WIID)Project No.TitleStatus
33578EN ISO 13485:2003/AC:2009Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)Atcelts
12987CR 13217:1998Nomenclature system for medical devices for the purpose of regulatory data exchange - RationaleAtcelts
22133EN ISO 13485:2003Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)Atcelts
21479EN ISO 14971:2000/A1:2003Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AM1:2003)Atcelts
28921EN ISO 13485:2003/AC:2007Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)Atcelts
40444EN 1041:2008+A1:2013Information supplied by the manufacturer of medical devicesAtcelts
24416CEN ISO/TR 14969:2005Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)Atcelts
21072EN ISO 14971:2000/AC:2002Medical devices - Application of risk management to medical devices (ISO 14971:2000)Atcelts
26098EN 15546-1:2008Small bore connectors for liquids and gases in healthcare applications - Part 1 - General RequirementsAtcelts
21726EN ISO 15225:2000/A1:2004Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange - Amendment 1 (ISO 15225:2000/A1:2004)Atcelts
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