Forest City Gear Achieves ISO 13485 Medical Certification

0
3453

Forest City Gear has announced it is one of the first gear manufacturers to successfully complete the achievement of ISO 13485, the process quality management certification for manufacturing medical devices. CEO Fred Young and President Wendy Young—along with Patrick Keeley, quality manager, who jointly coordinated the certification process—made this announcement. Everett Hawkins, director of sales, was also instrumental in facilitating the achievement of this certification for the company.

Forest City Gear is a manufacturer of various gear types with products found worldwide in aerospace and transportation uses as well as medical, military, industrial, and consumer product applications. The company is renowned for both its product quality and strict process control. The official receipt of this medical certification was made on February 15, 2008, and it positions the company to actively pursue the growing medical device market.
Gears are now in production at Forest City Gear for various medical devices, including such examples as a 4340 alloy steel gear for the articulation of the patient table in a magnetic resonance imaging (MRI) unit—as seen in the accompanying photo—as well as a brass gear for mechanical movement in an X-ray machine, a composite gear assembly for a blood infusion pumping station, and a specialty alloy gear for motion control on an artificial elbow mechanism. These and other medical gears are all engineered and manufactured at the company’s factory in Roscoe, Illinois.

“Fred Young drove this idea from the outset,” according to Keeley. “We’d been manufacturing various medical products over the years, and he saw substantial potential in that market for us.”

The company then contacted Brian Barch at Telosis, a firm that had assisted Forest City Gear in obtaining the AS 9100 aerospace certification in 2004. A thorough assessment of the Forest City Gear quality system was made, as certain specifications are mandated by the medical certification procedure. These include various limits on chemical and solvent utilizations, as well as strict environmental standards for emissions from the factory and the machinery used. Keeley explains that only minor adjustments were needed to bring the company into full compliance for medical certification, due largely to the existing conditions that were put into place for the previously achieved automotive and aerospace certifications at the company.

Forest City Gear was founded in 1955 by Evelyn and Stetler Young, parents of Fred Young. To learn more contact Everett Hawkins, director of sales, at (815) 623-2168 or ehawkins@forestcitygear.com. Visit online at [www.forestcitygear.com].