Been dabbling at the medical marketplace for years, SYNergy ScienTech Corp (6558) is pleased to announce that Kunshan SYNergy ScienTech Co., Ltd., its subsidiary, has officially received ISO 13485:2016 certification from SGS as of January 3rd 2023 for design and manufacture of battery cells and packs for medical related applications. This significant milestone will help expand business in medical applications by taking the advantage of our premium manufacturing capability being medical standard compliant.
ISO 13485 as medical devices quality management system is widely adopted worldwide to assist medical manufacturers in designing, establishing and retaining its process effectiveness and moreover, to ensure that manufacturers continue to design, develop, produce, install and deliver products of safety and satisfy their expectation of medical devices.
SYNergy’s customers are distributed throughout the world including Europe, North America and Asia. SYNergy has been in its world-class position, playing as a significant role in power supply design and manufacture of portable bluetooth headset, wireless speaker, smart watch, smart wearable, wireless mouse and keyboard, medical device and IoT, etc.
“With the acquirement of ISO 13485, SYNergy will continue to cultivate the field of medical consumables. By taking the advantages of competent research and development in Li-ion batteries, SYNergy will also continue to help the medical device manufacturers to enhance its competitiveness of their products, create differentiation and explore more collaborative opportunities”, said Colin Hsieh, President of SYNergy.