Kimball Electronics, Inc., a subsidiary of Kimball International, Inc. (NASDAQ: KBALB), announced today that the Company's production facility in Nanjing, China has achieved the stringent ISO 13485 certification for medical device manufacturing. Kimball Electronics (KEG) is a global top-twenty-ranked contract electronic manufacturing services (EMS) company that specializes in durable electronics with applications in the medical, automotive, industrial controls, and public safety industries.
The standard known as ISO 13485 – "Medical devices – Quality management systems – Requirements for regulatory purposes" has become the global standard for those involved in the manufacture of medical devices.
By obtaining the quality certification, Kimball Electronics-China became the sixth Kimball facility to hold certification for medical device manufacturing, providing customers with added options within the company's global footprint of operations. Kimball's other locations with ISO 13485 certifications are in Thailand, Poland, Mexico, Tampa (Florida), and Jasper (Indiana). "We are proud to now have ISO 13485 certification in all of our manufacturing facilities. The addition of this certification will allow us to support our medical customer's needs in the rapidly expanding healthcare market in China", stated Tom Ferris, Kimball Electronics Director of Medical Business Development.
Kimball Electronics-China benefited from existing strong quality management systems to address the processes and procedures related to medical device requirements. "Receiving ISO13485 certification in our Kimball Electronics China facility opens new opportunities for customers looking for quality medical production from Asia," remarked Roger Chang, Kimball Electronics Vice President of Asian Operations.
The medical segment is one of the largest of Kimball Electronics' focused markets. Among the types of products Kimball manufactures for the medical market are diagnostic imaging equipment, defibrillators, hematology, urinalysis, ultrasound and laboratory equipment, as well as vital signs, glucose and respiration monitors.
Within the highly specialized niche market of medical devices, Kimball Electronics has already established a solid foundation, with data showing the company ranks among the world's top percentile of leading medical electronics manufacturers.