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 |