31 October 2011
The Institute of Microelectronics (IME), an Institute of the Agency for Science, Technology and Research (A*STAR), today announce it has been awarded the ISO 13485:2003 (Medical Devices Standard) Certification for the design and development of medical devices. This certification augments the ISO 9001 certification which IME achieved in 1996 to better focus on fundamental requirements of the medical devices industry.
This international standard affirms IME’s ability to provide high quality project management, advanced technology, design and development activities that meet our partners’ requirements and industry regulations for the development of next generation novel medical devices. IME has initiated research programmes to collaborate with research and industry partners in the development of novel medical devices in the areas of Point-of-Care Diagnostics, In Vitro Diagnostics, Drug Discovery and Miniaturised Medical Devices.
“The convergence of biology and microelectronics technologies presents a unique opportunity for IME to leverage our multidisciplinary competencies in microelectronics technology to add value to our research and industry partners,” notes Prof. Dim-Lee Kwong, Executive Director of IME. “This certification is the latest step we have taken to realize our mission of positioning Singapore as the preferred R&D hub to develop next generation medical devices.”