Kimball Electronics Poland Operation Achieves Certification to ISO 13485

Kimball Electronics Group Inc., a subsidiary of Kimball International Inc. has announced that the company’s production facility near Poznan, Poland has achieved the necessary requirements for US FDA registration and ISO 13485 certification. Both the quality certification and US 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 company that specializes in durable electronics with applications in the medical, automotive, industrial controls, and public safety industries.

The company’s other locations with US FDA registrations and ISO 13485 certifications are in Thailand; Wales, UK; Tampa, FL, USA; Fremont, CA, USA and Jasper, IN, USA.

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 the company’s 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.

Tags: FDA, ISO 13485, Kimball Electronics Group, Kimball International Inc., US FDA, US Food and Drug Administration