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Picture of Successful ISO 13485 certification

Successful ISO 13485 certification

GATINES Ph.D Thierry
Publication date 23/03/2025
EAN: 9782487925588
Availability Available from publisher
19.90 €
Find out more: www.scobex-rgpd-dpo.fr and https://dpo-externe-rgpd-france.fr/. This book guides organisations in the implementation of ISO 13485, the quality management standard for medical devices. It details its regulatory framework, its requiremen... See full description
Detailed information
Attribute nameAttribute value
Common books attribute
PublisherTHEBOOKEDITION
Page Count137
Languagefr
AuthorGATINES Ph.D Thierry
FormatPaperback / softback
Product typeBook
Publication date23/03/2025
Weight189 g
Dimensions (thickness x width x height)0.90 x 14.80 x 21.00 cm
Summary
Find out more: www.scobex-rgpd-dpo.fr and https://dpo-externe-rgpd-france.fr/. This book guides organisations in the implementation of ISO 13485, the quality management standard for medical devices. It details its regulatory framework, its requirements and its interactions with other standards. It proposes a four-step methodology: gap analysis, planning, implementation and certification, with practical tools to ensure compliance and continuous improvement.