14 April 2015
14 April 2015
Whitford Corporation has established a new medical coatings group dedicated to supporting the use of its coatings on medical devices.
According to Whitford, the use of fluoropolymer coatings on medical devices have been historically dependable and offer many great benefits, despite a select few localised application issues that recently lead to FDA device recalls. Whitford says its medical coatings group is now in development, based at the company headquarters in Elverson, Pennsylvania, US; the operation will occupy a newly constructed facility that is expected to be fully operational by 3rd quarter 2015.
Whitford is redefining its position on the use of its coatings on medical devices. “As a raw material supplier for catheter guide wire manufacturers and coaters, as well as countless biocompatible devices, we understand the benefits of our coatings in medical applications. Our decision to establish a dedicated medical coatings group will enable us to support the use of our coatings in medical applications, and to safely be a key supplier to medical device manufacturers,” explained Dave Willis, Founder & CEO, Whitford Corporation.
In order to service all global tiers of the medical supply chain, Whitford says it will implement an ISO 13485 compliant quality system; validate all levels of manufacturing and enhance quality control testing to ensure product quality and performance. “ISO 13485 outlines the standard quality management system in the medical device supply chain,” explained Greg Lundell, Industry Manager of Medical Coatings, Whitford Corporation. “Complying with this international standard will allow us to meet global regulatory requirements.”
Investment in the new facility includes dedicated equipment, a new quality control laboratory with additional management and operations personnel. “Our aim is to establish ourselves as a global leader in medical coating supply,” said Lundell. “Having a dedicated facility reinforces our policy of providing exceptional quality and security of supply at a time when many other coating manufacturers are struggling to meet rising regulatory demands of the medical industry.”