Avalue has institutionalized ISO 13485:2003 certification
TAIPEI, TAIWAN, September 16th, 2013 – Avalue Technology Inc. (TAIEX: 3479-TW), is a global Embedded Solution provider and an Associate member of Intel® Intelligent Systems Alliance. In recent years, Avalue has dedicated itself to developing the medical segment including bedside terminals. First shipments to European markets have started since 2006 and have entered Canton, U.S. and Japanese markets since 2009. Avalue is the leading provider of bedside terminals and has a more than 50 percent market share globally.
Databeans research has pointed out that the global medical electronics market reached 1,560 billion U.S. dollars in 2011, increased about 1,680 billion U.S. dollars in 2012. Now it is estimated to reach 2,432 billion U.S. dollars in 2016. Developments in the health care system are showing tremendous change in medical products trend; traditionally designed for hospitals and for the only use of a physician, such products are now being designed to be more patient friendly.
ISO 13485:2003 is a management system standard generally harmonized with ISO 9001:2000, which is specifically developed for the manufacture of Medical Devices. Its purpose is to meet regulatory requirements including design, development, manufacture, installation and services:
- Implementation of a Quality Management System with several enhancements
- Risk Management approach to product development and product realisation
- Validation of processes
- Compliance with statutory and regulatory requirements
- Effective product traceability and recall systems
“Avalue has institutionalized the ISO 13485:2003 certification since June 2013, thus committing ourselves to meeting the most up to date standards and ensure quality remains the standard for all Avalue made products. With the ISO 13485:2003 certification, we expect growing sales for health care segment.” said Philip Chang, General Manager of Avalue. European Union, United States and Canada account for more than 70% of medical devices market globally. ISO 13485:2003 is the primarily quality management system for the EU, specifically for medical devices. As the world enters aging population stage, demand for medical devices will definitely increase. Meeting the ISO 13485:2003 requirement is a great achievement for Avalue thus showing our ability to provide products that consistently meet the requirements of customers and applications.
More product information, please visit Avalue website at www.avalue.com.tw, or contact with firstname.lastname@example.org for more details.
About Avalue Technology
Avalue Technology （TAIEX: 3479-TW） is a professional industrial computer manufacturing company, which is dedicated to developing the x86 architecture products, including embedded computers, single board computers （SBC）, Systems-on-Modules/ ETX （SoM/ ETX）, industrial motherboards, all-purpose panel PCs, and barebone products, etc. Having expanded, Avalue offers its expertise on PCB/ Assembly/ BIOS version control and after-sales all type of services. An ISO 9001:2008 certified company; Avalue offers assurance to customers in every aspect of its business. With its headquarter located in Taiwan, Avalue has global subsidiary company, including offices in Shanghai, New Jersey, California,Tokyo, and Denmark. In addition, Avalue Technology operates an extensive distribution network to accommodate and serve customers all over the world.