Kimball Poland medical certified

Both the quality certification and FDA registration help broaden the Poland facility's package of value to better serve new customers. Kimball Electronics Group (KEG) is a global 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. Requirements for registration to ISO 13485 were met first, and then commonly used as the basis for U.S. Food and Drug Administration (FDA) registration. Kimball's other locations with FDA registrations and ISO 13485 certifications are in Thailand, Wales (U.K.), Tampa (Florida), Fremont (California), and Jasper (Indiana). Kimball Electronics-Poland was able to benefit from the collective knowledge of its sister locations that have ISO 13485 certification, built upon existing strong quality management systems to address the processes and procedures related to medical device requirements. 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. The medical segment is the largest of Kimball Electronics' four focused markets. A portion of the Poland facility is dedicated to the medical market with a controlled environment, medical laboratory and a devoted team specifically for medical instruments and disposables. The team works to develop processes and equipment to support customer specifications while reducing total product cost.