Arazy Group – Medical Device Consultants
Arazy Group –Quality Management System Requirements - CE regulation – ISO13485
Arazy Group –Quality Management System Requirements - FDA regulation – QSR
Arazy Group – Latest news on Medical Devices Regulation

Arazy Group – Relevant Articles about Medical Devices Regulation
If you want to know more about regulatory issues of Medical Devices, click here.
 
 
Arazy Group Home » Quality Management System » CE QMS Requirements
 
 
CE QMS Requirements
 
You will need to establish and maintain a Medical Quality Management System compliant with the 93/42 EEC Medical Device Directives. The European authorities accept the ISO 9001:2000 and the ISO 13485:2003 quality standards as a basis upon which the Medical Quality Management System can be built. However, you should avoid the hassle of reinventing the wheel and use ISO 13485:2003, which is specific of the medical devices industry.
A Notified Body will perform the Medical Quality Management System audit before you are authorized to affix the CE mark on the devices.
The 93/42 EEC Medical Device Directives allows for different scopes of your Medical Quality Management System: full quality system, production quality system, or product quality system. Usually the implementation of a full quality system is the most convenient approach.
 
Arazy Group –Quality Management System Requirements – CMDCAS regulation – ISO13485
Arazy Group – Medical Device Regulation - What is CE mark and FDA approval? – FAQs
Arazy Group – Medical Device Regulation – Online Products
 
 
Arazy Group – Medical Device Consultants Arazy Group – Medical Device Consultants Arazy Group – Medical Device Consultants Arazy Group – Medical Device Consultants
2005 Copyright Arazy Group. All rights reserved. | Private Policy