Dongguan Chamax Technologies Co., Ltd. is a specialized OEM and ODM manufacturer of high-precision wire harnesses, PCBA, and electronic assemblies, today announced it has successfully upgraded its medical quality management system to the latest international standard. The company was awarded the ISO 13485:2016 certification on May 27, 2019, building upon its initial certification to the ISO 13485:2003 standard first achieved on March 30, 2016.
This certification is the international benchmark for Quality Management Systems (QMS) in the medical device industry. The upgrade to the 2016 version underscores CHAMAX’s ongoing commitment to the highest levels of quality, risk management, and regulatory compliance in the manufacture of critical components and products for the medical sector. The rigorous audit process validates CHAMAX's systematic approach to ensuring the safety, reliability, and consistency of its manufacturing processes for medical applications.
This achievement is a testament to our unwavering focus on quality and patient safety. Our initial certification in 2016 marked our entry into the medical manufacturing field, and this upgrade to the latest 2016 standard reflects our deep commitment to continuous improvement and excellence. For our global partners, this provides essential assurance that their medical devices are built by a supplier with a proven, robust QMS that meets the most stringent international requirements, mitigating risk and streamlining their path to market.
For B2B clients in the medical technology field, partnering with an ISO 13485:2016 certified manufacturer like CHAMAX significantly reduces supply chain risk. It ensures that products are designed and manufactured under a process that emphasizes risk-based decision making, traceability, and strict regulatory adherence, which is critical for approvals in global markets.
CHAMAX is a trusted OEM and ODM manufacturing partner specializing in the design and production of custom wire harnesses, printed circuit board assemblies (PCBA), and full product assembly. With a strong focus on the computing, consumer, communication, and medical industries, CHAMAX empowers global brands through engineering excellence, rigorous quality management, and a commitment to customer success.