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    After completing this module, you will be able to:

    Discuss all requirements stated in Clause 8 of ISO 13485:2016.
    Explain the requirements on Monitoring and Measurement.
    State controls so as to manage non-conforming product.
    Describe the complaint handling procedure in the case of medical devices.
    Specify the requirements on analysis of data.
    Outline the process of Improvement with its requirements. 
    Differentiate correction, corrective action and preventive actions.
    Summarize the 7-Steps protocols for corrective and preventive actions.
    Comprehend why companies fail to effectively implement corrective and preventive actions.