• 6661cc010468607a788e48b1 Applicationofriskmanagementtomedicaldevic
    1. Learning Resources
    2. White Papers

    Application of Risk Management to Medical Devices: Introduction to ISO 14971:2019

    June 12, 2024
    Risk Management is a top priority for Medtech developers. Ensure the safety and success of medtech innovations with essential tools and strategies needed to effectively manage risk. This ebook outlines those tools and strategies you can apply today.

    Medical devices are crucial in healthcare, requiring stringent safety measures. Risk management is a top priority for manufacturers to ensure patient and operator safety. With increasing device complexity, regulatory agencies emphasize risk management, guided by standards like ISO 14971:2019. This standard outlines a systematic risk management process to help manufacturers produce safer, high-quality medical devices.

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