About the Course
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Lesson 1 - Overview of the Regulatory Framework of Medical Device and IVDs
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Lesson 2 - BIS Activities on Medical Devices
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Lesson 3 - Materiovigilance Programme of India (MvPI): An Overview
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Lesson 4 - IndiaPerformance Evaluation/ Clinical Performance Evaluation of In-Vitro Diagnostic Kits
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Lesson 5 - Introduction to Medical Device Risk Classification
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Lesson 6 - Design Controls for Medical Devices
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Lesson 7 - Medical Device Risk Management
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Lesson 8 - Quality Management Systems
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Lesson 9 - Testing and Certification of Medical Devices
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Lesson 10 - Transition: Licensing on Sugam Portal
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Lesson 11 - Transition: Licensing in Online Portal
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Lesson 12 - Regulatory Requirements on IVD Instruments/Analyzers and IVD Software
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Lesson 13 - IVD Stability Studies: An Overview
12 CDSCO Capacity Building Training
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Assessment
Check Your Knowledge
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Discussion Forum
Discussion Forum
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Feedback
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Certificate
Preparedness for Transition to Licensing Under Medical Devices Rules (MDR) (Certificate)
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