About the Course
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No Instructor(s)
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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
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Post Assessment
Assessment
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Certificate
CSDCO Certificate
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