About the Course
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Implementation of Quality Management System (QMS)
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
Clinical Investigation & Clinical Performance evaluation of Medical devices
Device Master File
Quality Management System for Medical Devices
Essenstial Principles of safety and performance of Medical Devices & IVDs
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
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Certificate
Certificate
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