Medical Apparatus and Instruments

Course Course Length/ day
How to set up the management system of medical equipment 1
Introduction and understanding of the laws and regulations of medical devices 1
ISO13485 internal auditor training 2
ISO13971 medical device risk management evaluation method 2
CMDCAS Canada medical device quality management system requirements 2
JGMP Japan medical device quality management system requirements 2
QSR820 United States FDA medical device quality management system requirements 2
In depth understanding of the EU Directive on 93/42/EEC medical devices 2
IEC 62304 life cycle of medical device software 2
Introduction and understanding of the laws and regulations of medical devices (Europe, America, Japan, Canada, Australia, Brazil and other key countries) 3