ISO Certification for Medical Products Traceability and Trackability Awarded to Saline Lectronics

PRESS RELEASE
FOR IMMEDIATE RELEASE

Contact: Sandra Jacobs
Office: 734-944-2120

Saline, MI February, 2008 – Saline Lectronics has been awarded ISO 13485:2003 certification in recognition for the exceptional quality of their process and their product that meets or exceeds the standards of the ISO. This certification, from the International Organization for Standardization (ISO) in Geneva, Switzerland, affirms that Saline Lectronics has put in place a comprehensive system for the design and manufacture of medical devices and guarantees that Saline Lectronics meets necessary regulatory requirements for medical PCB assembly.

ISO 13485:2003 supplements ISO 9001:2000 by providing additional requirements for the medical industry in the areas of design and process controls, special processes, traceability, record retention, and regulatory actions. Forward-thinking companies that implement this system take a world-class approach to the manufacture of medical devices that ensures patient safety. Saline Lectronics will gain a competitive edge in manufacturing devices for the global market like medical and laboratory equipment, biomedical analytic instrumentation, and implantable devices. Certified ISO 13485:2003, Saline Lectronics is a leader in medical PCB manufacturing.

Recent process enhancements include integrated inventory management and tracking software that provides point of use trackability for circuit board components, additional staff training, and new automated optical inspection machines to monitor process quality and prevent the production of defects. Saline Lectronics has enhanced their process and training to meet the specific needs of both current and prospective clients.

Saline Lectronics provides comprehensive circuit board manufacturing services including contract design, material procurement, and PCB assembly. With over 90 employees and 115 years of combined management experience in electronics, Saline Lectronics is well known for their superior customer service, available inventory, and versatility in responding to customer needs. Their clients include manufacturers of biomedical equipment, aerospace related circuits, parking attendant equipment, electrical manufacturing, data communications, industrial controls, instrumentation, oil and gas drilling industry, and even components used by the U.S. Military.