HBK’s Suzhou production site achieves ISO 13485 certification

HBK, a specialist in test and measurement solutions, has announced that its Suzhou production site has recently obtained ISO 13485 certification. The company says the achievement demonstrates HBK’s commitment to the quality and safety of medical devices.

ISO 13485 certification is an accreditation specifically designed for medical device manufacturers. It ensures that the design, development, production and distribution of medical devices comply with regulatory requirements and meet customer expectations. HBK says that by obtaining this standard, it strengthens its reputation as a trusted provider in the medical industry.

The ISO 13485 standard enables HBK to adopt a systematic approach to optimising processes and mitigating risks according to the company. HBK says that by proactively identifying potential hazards and streamlining workflows, it promotes operational efficiency, reduces waste, and improves productivity.

“This significant certification milestone is an opportunity for each one of us to embrace our commitment to quality, safety, and continuous improvement,” said Yin (Albert) Hou, Quality Manager at HBK. “As a leading provider of advanced medical devices, we celebrate this achievement together and reinforce our reputation as a trusted partner for innovators worldwide.”

HBK says the ISO 13485 certification in Suzhou marks a “remarkable” milestone in its journey. The company says it is innovation-driven and is committed to empowering innovators, exceeding expectations, and making a lasting impact on the medical industry.

HBK also provides a portfolio of technologies that cover “the entire test and measurement life cycle” across every domain according to the company. Sensor hardware and data acquisition systems (DAQs) remain at the heart of the offering says HBK, but it also provides data management and analysis software, as well as simulation software and hardware.