Successful ISO 13485 certification
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- Paiement en ligne :
- Livraison à domicile ou en point Mondial Relay indisponible
- Retrait Click and Collect en magasin gratuit
- Nombre de pages137
- PrésentationBroché
- Poids0.191 kg
- Dimensions14,8 cm × 21,0 cm × 0,9 cm
- ISBN978-2-487925-58-8
- EAN9782487925588
- Date de parution23/03/2025
- ÉditeurTHEBOOKEDITION
Résumé
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.
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.
