• Effective Risk Management For Medical Devices

    10 days ago - By PSC Biotech

    Written By: Crystal McCain, PSC Biotech®
    Risk Management is your system of management policies, procedures, analysis practices, and monitoring risk. An effective risk management program is an essential element in the life cycle of a medical device.
    A Hazard is a potential source of harm. A Risk is your estimated probability that a Hazard occurs for your medical device and the severity of that Hazard to patients, users, etc. So, how do you do risk management? You start with ISO 14971 .
    ISO 14971 is the International Standard that specifies terminology, principles and a process for risk...
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