Medical devices - the basics
Ensure quality management and risk mitigation for medical devices with our ISO standards bundle, tailored for compliance and practical implementation.
This bundle includes 4 products:
- ISO 13485:2016 Requirements for regulatory purposes
- ISO 13485:2016 - Medical devices: A practical guide
- ISO 14971:2019 Application of risk management to medical devices
- ISO/TR 24971:2020 Guidance on the application of ISO 14971
Medical devices - the basics
Medical devices - the basics 10% discount
Digital version (PDF), English
Medical devices - the basicsCHF 658pub200422CHF 592Convert Swiss francs (CHF) to your currency
Why choose this bundle?
This bundle combines essential ISO standards to provide a robust framework for quality management and risk management in the medical device industry. ISO 13485:2016 sets the foundation for a quality management system, ensuring that organizations consistently meet regulatory (if applicable) and customer requirements. The practical guide helps in the effective implementation of the standard. ISO 14971:2019 focuses on identifying and mitigating risks associated with medical devices, and ISO/TR 24971:2020 offers detailed guidance on applying risk management principles. Together, these standards ensure that your organization delivers safe and effective medical devices.
Bundle content
- ISO 13485:2016Dispositifs médicaux — Systèmes de management de la qualité — Exigences à des fins réglementaires
- ISO 13485:2016 - Medical devices - A practical guideManuel pour les organismes souhaitant établir, mettre en œuvre et maintenir un système de management …
- ISO 14971:2019Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux
- ISO/TR 24971:2020Dispositifs médicaux — Recommandations relatives à l'application de l'ISO 14971