Successful ISO 13485 certification

For further information, visit www.audiciaux.fr, www.scobex-rgpd-dpo.fr and www.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.