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Developing medical device software in compliance with regulations.

M Zema, S Rosati, V Gioia

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    Summary
    This summary is machine-generated.

    Information technology (IT) in healthcare improves patient care but presents regulatory challenges. This study introduces a framework for developing safe, high-quality medical device software, aligning development with standards.

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    Area of Science:

    • Health Informatics
    • Software Engineering
    • Regulatory Science

    Background:

    • Information technology (IT) adoption in healthcare has increased, offering benefits for patient care and resource access.
    • The integration of IT in healthcare introduces new challenges, particularly concerning the regulation of healthcare software.
    • Software used in healthcare may be classified as medical devices, requiring adherence to specific regulations based on its function and use.

    Purpose of the Study:

    • To present a software development framework for creating safe and high-quality medical device software.
    • To map software development phases to relevant industry standards and regulations.

    Main Methods:

    • Development of a structured software development framework.
    • Analysis of regulatory requirements for medical device software.
    • Correlation of development lifecycle phases with applicable standards.

    Main Results:

    • A framework is proposed to guide the development of medical device software.
    • The framework ensures that software development aligns with safety and quality standards.
    • Clear correspondence is established between development stages and regulatory compliance.

    Conclusions:

    • The proposed framework facilitates the production of safe and high-quality medical device software.
    • Adherence to the framework ensures compliance with relevant medical device regulations.
    • This approach addresses the challenges of implementing IT in healthcare by providing a structured development process.