HBK’s Suzhou Production Site Achieves ISO 13485 Certification

Reinforcing Commitment to Quality and Safety in Medical Devices

HBK, a global leader in test and measurement solutions, is proud to announce that its Suzhou production site has recently obtained ISO 13485 certification. This achievement demonstrates HBK’s unwavering commitment to the quality and safety of medical devices.

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

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.”

The ISO 13485 certification in Suzhou marks a remarkable milestone in HBK’s journey. As an innovation-driven company, we are committed to empowering innovators, exceeding expectations, and making a lasting impact on the medical industry.

For more information about HBK’s ISO 13485 certification in Suzhou, please contact Yin (Albert) Hou, Quality Manager in Suzhou, at albert.hou@hbkworld.com.

About the ISO 13485 Standard:

ISO 13485 is an international standard for Quality Management Systems (QMS) specifically designed for the medical device industry. It ensures that the design, development, production, and distribution of medical devices comply with regulatory requirements and customer expectations. Based on the ISO 9001 standard, ISO 13485 includes additional requirements specific to the medical device industry.

About HBK:

HBK provides a complete portfolio of technologies that cover the entire test and measurement life cycle across every domain. While sensor hardware and data acquisition systems (DAQs) remain at the heart of our offering, we also provide state-of-the-art data management and analysis software, as well as simulation software and hardware. So whether you are a developer or a manufacturer, we are ready to support you at every stage of the product development and optimization process including:

• Physical and virtual testing for more innovative R&D
• In-line measurement and end-of-line testing for manufacturing control and efficiency
• In-product sensing and in-service monitoring to maximize product quality for Original Equipment Manufacturers (OEMs)

On one hand, this means that engineers have the tools they need to accelerate development cycles while maintaining production efficiency and quality. On the other, OEMs can continuously and reliably optimize performance through sophisticated in-product measurement and monitoring.