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The development and design of KINBAY is a complex process with medical industry regulations, specifications, application requirements, and patients' needs.

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The manufacture of KINBAY involves the following stages: medical material and processes specification, vendor selection, detailed part design, software fine-tuning and testing, failure mode analysis, and tolerance analysis.

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KINBAY has to undergo a conformity assessment to demonstrate that it meets legal medical requirements to ensure it is safe and performs as intended.

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The quality of KINBAY is guaranteed. It is manufactured in a highly regulated environment where quality systems like FMEA are key to medical device manufacturing.

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Typical parameters of KINBAY being measured include flexure, tension, compression, peel strength, adhesive/bond strength, puncture, insertion/extraction and sliding of pistons.

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KINBAY has been tested for many times. It has been inspected in terms of medical materials characterization, biocompatibility, durability, and human factors.

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The product has compatibility with living tissue or a living system by not being toxic, injurious, or physiologically reactive and not causing immunological rejection.

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