About the Course
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Overview of Regulatory Framework
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Materiovigilance - Adverse Event Reporting and Analysis
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Performance Evaluation Clinical Performance Evaluation of In- Vitro Diagnostic Kits
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Medical Device Risk Classification
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Design Controls Training Package Final
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Design Controls For Medical Devices
PDF
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Medical Device Risk Management -
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Quality Management Systems
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Testing of medical devices - TIC
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Transition Licensing on Sugam portal
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Regulatory Requirements on IVD Instruments
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Stability Study Requirements for IVD Kits including Reagents
PDF
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Certificate
CDSCO Certificate
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