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Medical Device File

    Definition of a Medical Device File

    A Medical Device file is a comprehensive documentation that provides detailed information about a medical device. It is a crucial component of the regulatory compliance process for medical devices, ensuring that they meet safety and performance standards set by regulatory authorities such as the Food and Drug Administration (FDA) in the United States.

    Importance of a Medical Device File

    The medical device file is a comprehensive record of the device’s development, testing, and regulatory compliance, providing evidence of its safety and efficacy for approval and ongoing market surveillance. It is typically submitted to regulatory authorities as part of the application process for market authorization or approval to commercialize the device.

    Regulatory Requirements for Medical Device Files

    The regulatory requirements for medical devices depend on which regulatory body the device is being submitted to. The requirements generally include various documentation about the design and conception of the device design plan, design control form, approved supplier list, test protocols and reports, and risk documentation.

    Overview of Regulatory Authorities

    FDA- 21 CFR 820 Medical Devices- Quality Systems Regulations

    International- ISO 13485:2016

    Canada- SOR/98-282 Health Canada

    EU- Medical Device Regulation

    Types of Medical Devices Requiring an MDF

    All medical devices require a medical device file regardless of the risk level classification.

    Legal Requirements for Medical Device Files

    Legal requirements include

    Components of a Medical Device File

    Design plan

    Quality Plan

    Risk Management Plan

    Design Control


    Hazard Analysis

    Design Transfer plan

    Software Documentation

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