Module 16 2022

Application of Post Market Survelliance (PMS) • Verification of your risk analysis • Improving medical device quality • Lowering risk associated with the device • Detecting and mitigating or fixing any manufacturing problems, including things like defects with the casing or packaging the device is transported in • Long-term performance data and knowledge of any trends • Data on different user populations - this can help you determine if your risk assessment needs to be split by patient population

• Intelligence on any misuse of the device • Feedback for training or labeling required • Data on use with any other devices • Data on market performance and sustainability

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Business Use Only