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Medical Device Regulatory Affairs - Coggle Diagram
Medical Device Regulatory Affairs
Unit I - Medical Devices
Definition
Classification of medical devices
Product life cycle of medical device
International Medical Device Regulators Forum (IMDRF)
Summary Technical Document (STED
Global Medical Device Nomenclature (GMDN)
Unit- II
Ethics of Clinical Trials of Medical Devices
Clinical Investigation Plan
ISO 14155:2020
ISO 13485:2016
ISO 14971:2019
Validation and Verification
Adverse Event Reporting
Unit- III
Regulations of Medical Devices in United States
US FDA
Premarket Notification 510(k)
Approval process of Medical Devices
21 CFR
Quality System Requirements 21 CFR Part 820
requirements 21 CFR Part 801
Post marketing surveillance
Unique Device Identification (UDI)
PreMarket Approval (PMA)
Unit- IV
Regulations of Medical Devices in Europe
Regulatory approval process for Medical Devices
EU MDD
EU MDR
Notified Bodies
CE Marking
Labelling requirements
EU MDR Quality Management System
Unit- V
Regulations of Medical Devices in India
CDSCO
MDR -2017 and MDR-2020
Approval Process of Medical Devices
Import of medical devices
Regulations for Clinical Trials
Recall of Medical Devices
Labelling of Medical Devices