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  • Yiming Cheng replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 8 years, 5 months ago

    There could be multiple ways to identify risks. To my understanding, following lists can be considered:

    Identify the hazards that could possibly affect the safety of your medical device.

    Document the known and foreseeable hazards that could affect the safety of your medical device.

    Use your risk management file to maintain the documents that identify and describe the hazards that could affect the safety of your medical device.