November 30, 2010: Arazy Group is a medical device consultant which performs several tasks for clients like bringing market approvals from essential public health authorities, brings clinical evaluation, CMDCAS approval and much more.
Medical devices are needed to go through different section to prove their capability, quality and affectivity as well. And quality assurance of medical equipments is important to make them suitable for international market.
As far as quality assurance of medical devices of Arazy Group is considered. Products which are three years old are needed to get high quality standard assurance. Device manufacturing companies are needed to come with the standards accepted by the target market authorities like:
• The quality standards of European authorities including the ISO 13485:2003 and the ISO 9001:2000. Such standards are active in different European Community countries and are applicable with the 93/42 EEC Medical Device Directives.
• QSR which stands for Quality System Regulation is published by FDA which is an American regulatory agency.
• Medical Device Regulations document is published by Canadian ministry of health which refers the ISO 13485:2003.
Other countries come with different medical device standards which can be easily implemented as per the request of medical device producing companies in UK, EU member states, North and South America, Far East and Middle East.
About Arazy Group:
Arazy Group brings market approvals to medical devices through its branches in Middle East, EU member states, Far East, South America and many others. Its special feature includes bringing FDA Clearance, clinical evaluation, CMDCAS approval and much more to medical devices before presenting them in international market.
Source(s)
http://www.prlog.org/11111421-quality-assurance-of-medical-devices.html
Medical Device Consultants | Medical Devices Experts | Medical Lab Equipment
Arazy Group - Medical Device Consultants | Medical Device Registration
Arazy Group expertise is regulatory affairs and quality assurance for the medical device industry. We specialize in marketing safe and effective Medical Technology to international markets. Our experienced consultants are responsible for the successful registration of thousands of medical devices globally. Our customized solutions accommodate all stages of medical device's life cycle and our adaptable services fit any application and any size organization.
Very informative blog, thanks for sharing....
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