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Implementation of Quality Management System (QMS) in Medical Devices
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Implementation of Quality Management System (QMS) in Medical Devices

About the Course

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  • Implementation of Quality Management System (QMS) in Medical Devices

    Regulation of Medical Devices

    Design Control & Development aspects of Medical Devices

    Biocompatibility & Biological Safety Assessment of Medical Devices

    Regulatory Requirements for in Vitro Diagnostic Device

    Classification of Medical Device, IVD

    Device Master File

    Quality Management System for Medical Devices

    Risk Management requirements for medical devices

    Disciplining Manufactures Effective compliance Mechanism

    Materiovigilance Adverse Evenet Reporting and Analysis

    Regulatory Inspection Non Compliances observations

    Role of Standards in Quality of Medical Devices

    Use of Symbol and Labelling requirement for Medical Devices & IVD

    Soft skills

    Medical Device Portal

  • Post Assessment

    Assessment

  • Certificate

    CSDCO Certificate

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This course includes

  • PDF
  • Assessment
  • Certificate
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