Registration number (WIID)Project No.TitleStatus
64861CEN/TR 17223:2018Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices RegulationAtcelts
24868EN ISO 15225:2000/A2:2005Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000/Amd 1:2004)Atcelts
24162EN ISO 14971:2007Medical devices - Application of risk management to medical devices (ISO 14971:2007)Atcelts
40444EN 1041:2008+A1:2013Information supplied by the manufacturer of medical devicesAtcelts
64861LVS CEN/TR 17223:2018Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices RegulationAtcelts
21072EN ISO 14971:2000/AC:2002Medical devices - Application of risk management to medical devices (ISO 14971:2000)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
59550LVS EN ISO 15223-1:2017Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2016-12-15)Atcelts
12988EN 980:2003Graphical symbols for use in the labelling of medical devicesAtcelts
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