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Displaying 1-12 of 20 results.
LVS EN ISO 13485:2016
standard
EN
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
22.71 €
LVS EN ISO 13485:2016/A11:2021
amendment
EN
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
16.11 €
LVS EN ISO 13485:2016/AC:2017
corrigendum
EN
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
0.00 €
LVS EN ISO 13485:2016/AC:2018
corrigendum
EN
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
0.00 €
LVS EN ISO 14971:2020
standard
EN
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
20.33 €
LVS EN ISO 14971:2020/A11:2022
amendment
EN
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
9.78 €
LVS EN ISO 15223-1:2017
standard
EN
Medical 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)
19.28 €
LVS EN ISO 15223-1:2021
standard
EN
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
22.71 €
LVS EN ISO 15225:2016
standard
EN
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
14.26 €
LVS CEN/TR 17223:2018
technical report (TR)
EN
Guidance 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 Regulation
25.88 €
LVS CEN ISO/TR 20416:2020
technical report (TR)
EN
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
21.39 €
LVS EN ISO 20417:2021
standard
EN
Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021,Corrected version 2021-12)
25.88 €