ROSCOE, IL, October 28-Forest City Gear has achieved ISO 13485 certification, the quality management certification for manufacturing medical devices.
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 official receipt of this medical certification was made on February 15, 2008.
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 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, IL, northwest of Chicago.
“We’d been manufacturing various medical products over the years and saw substantial potential in that market for us,” says Patrick Keeley, quality manager for Forest City Gear.
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. Only minor adjustments were needed at Forest City Gear to bring the company to 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.