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    After completing this module, you will be able to:

    Discuss the organizational requirements related to Quality Management System of ISO 13485.
    Summarize all the requirements of auditable Clause 4.
    Study the requirements on medical software validation and how are these maintained.
    Outline the specific documentation requirements for medical devices' QMS.
    Explain the management process of medical device files.
    Describe the elements of medical device files
    Express the requirements of Clause 5 for top management in medical devices company.
    Explicate the process of management reviews along-with its inputs and outputs.
    List all the requirements of Clause 6 regarding resource management.
    State particular requirements of sterile medical devices.