Global Unichip Achieves Critical ISO 13485:2016 Certification for Medical Device Components

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Hsinchu, Taiwan, Oct. 25, 2017 – The leading custom ASIC company, Global Unichip Corp. (GUC), today announced the achievement of highly coveted ISO 13485:2016 certification, which make GUC the first and only ASIC company to meet these demanding standards and will strengthen qualities of medical IC design and manufacturing services.

"With this certification, GUC could demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements and would help our customers jump into technology leadership positions in key medical device segments," explained Dr. Ken Chen, president of GUC.

GUC was awarded ISO 13485 certification for its quality management system and design and manufacturing services for semiconductor medical device components. The certification came after a comprehensive audit conducted by DQS in late June 2017 which validated GUC's services are in compliance with all ISO 13485 requirements and demonstrates that GUC's capability to support medical device customers' products in compliance with requirements of applicable regulations and of markets.

GUC's services cover semiconductor IP development and implementation, IC design service, semiconductor manufacturing, engineering verification, and production control operations. The completed medical service package implements risk management, competitive technical solution, and a unique zero defect program aimed at IC defect elimination.

Moreover, the zero defect program includes DFx methodologies to deliver design for testability, design for manufacturability, design for reliability, documentation, traceability, supplier management, and audit process and regulation compliance.

GUC is already an experienced leading custom ASIC company. The certification, ISO 13485, once again proves GUC's design and quality control capabilities. For more details on GUC comprehensive full package services, please visit: http://www.guc-asic.com/en-global

About GUC

GLOBAL UNICHIP CORP. (GUC) is the Custom ASIC Leader, who provides the semiconductor industry with leading IC implementation and SoC manufacturing services. Based in Hsin-chu Taiwan, GUC has developed a global reputation with a presence in China, Europe, Japan, Korea, and North America. GUC is publicly traded on the Taiwan Stock Exchange under the symbol 3443. For more information, visit www.guc-asic.com.

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