Module 16 2022

Application of PMS continue...

Your post-market surveillance should inform a few risk management points; • Do changes need to be made to your device? • Do you need to change how you label, market or educate on the device? • Do you have a systematic process for evaluating the data you collect? • Do you have objective evidence in your risk management file for any assumptions being made? • Are changes required to your risk acceptability definitions?

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Business Use Only