PUB200422
Medical devices - the basics
Титульный лист: Medical devices - the basics
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
pub200422
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    Digital version (PDF), English

    CHF 658
    Medical devices - the basics
    pub200422
    Language
    Format
    CHF 592
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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

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