The Suzhou Manufacturing Facility of HBK Gets ISO 13485 Certification


HBK, a global pioneer in test and measurement solutions, has announced that its Suzhou production location has become ISO 13485 certified.

The renowned ISO 13485 certification was created especially for companies that make medical devices. It guarantees that medical device design, development, manufacture, and distribution fulfil consumer expectations and adhere to strict regulatory criteria. By achieving this globally acknowledged standard, HBK enhances its standing as a reliable supplier in the medical field.

At HBK, our commitment to excellence goes beyond mere compliance. The ISO 13485 standard enables us to adopt a systematic approach to optimizing our processes and mitigating risks. By proactively identifying potential hazards and streamlining workflows, we promote operational efficiency, reduce waste, and improve productivity. This certification not only enhances our competitive advantage but also demonstrates our dedication to delivering superior-quality outcomes.

“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. “As a leading provider of advanced medical devices, we celebrate this achievement together and reinforce our reputation as a trusted partner for innovators worldwide.”

Suzhou’s ISO 13485 accreditation is a significant turning point in HBK’s history. We are dedicated to supporting innovators, going above and beyond, and leaving a lasting impression on the medical sector as an innovation-driven organization.



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