Forest City Gear Achieves ISO 13485

One of First Gear Manufacturers to Achieve ISO 13485

Forest City Gear is one of the first gear manufacturers to successfully complete the achievement of ISO 13485, the process 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 has been completed and positions the company to actively pursue their growing medical device market.

Gears are now in production 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.

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.