About the Course
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Regulation of Medical Devices
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Design Control & Development aspects of Medical Devices
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Biocompatibility & Biological Safety Assessment of Medical Devices
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Regulatory Requirements for in Vitro Diagnostic Device
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Classification of Medical Device, IVD
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Clinical Investigation & Clinical Performance evaluation of Medical devices
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Device Master File
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Quality Management System for Medical Devices
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Essenstial Principles of safety and performance of Medical Devices & IVDs
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Risk Management requirements for medical devices
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Disciplining Manufactures Effective compliance Mechanism
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Materiovigilance Adverse Evenet Reporting and Analysis
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Regulatory Inspection Non Compliances observations
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Role of Standards in Quality of Medical Devices
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Use of Symbol and Labelling requirement for Medical Devices & IVD
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Soft skills
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Medical Device Portal
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Post Assessment
Assessment
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Certificate
CSDCO Certificate
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