Whitford announces new Medical Coatings Group to be certified to ISO 13485
April 2015, Elverson, PA. Whitford Corporation, manufacturer of the world’s largest, most complete line of fluoropolymer coatings for industrial and consumer industries, is establishing a new Medical Group dedicated to the use of high-performance fluoropolymer coatings on medical devices. Fluoropolymer coatings have been successfully used on medical devices for many years, offering a variety of important benefits. The Medical Group is located at the company headquarters in Elverson, Pennsylvania, and will occupy a newly constructed high-tech facility expected to be fully operational by the 3rd quarter of 2015.
Whitford will seek ISO 13485 quality-system certification. “As a raw-material supplier for catheter guide-wire manufacturers and coaters, as well as countless biocompatible devices, we understand the benefits of ISO-certification for all global tiers of the medical market. Our dedicated medical-coatings group will enable us to support the use of our coatings in medical applications, and to be a reliable, safe supplier to medical-device manufacturers,” explained Dave Willis, founder and CEO of Whitford.
“ISO 13485 outlines the standard quality management system in the medical-device supply chain,” said Greg Lundell, Industry Manager of Medical Coatings for Whitford. “Complying with this international standard will allow us and, more important, our customers, to meet global regulatory requirements.”
Investment in the new facility includes new, dedicated equipment, as well as a separate quality-control laboratory with management and operations personnel. “Our aim is to become a global leader in medical-coating supply,” added 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 the rising regulatory demands of the medical industry.”
For more information, call Greg Lundell at 484-986-8328.
MEDICAL DISCLAIMER (In effect until Whitford’s new Medical Coatings Group is fully operational toward the end of 2015.)
Whitford coatings and related materials are designed and manufactured for industrial and consumer uses and applications only, and are not designed or manufactured for medical uses or applications. Whitford does not manufacture or supply any medical grades of coatings or other materials, and has not conducted any clinical tests or studies concerning the suitability or efficacy of its coatings and other materials in medical uses or applications. Whitford has not sought or received any approvals or other rulings from the U.S. Food and Drug Administration or any other governmental or regulatory agency (federal or state) concerning the use of its coatings or other materials for medical applications.
Persons who contemplate the use of Whitford coatings and other products for medical applications must undertake their own clinical tests and other studies to determine the safety and efficacy of the coatings and other products for medical applications. Such persons must make their own independent evaluation and judgment concerning the safety and efficacy of Whitford coatings and other products in medical applications and must not rely on Whitford or on any information relating to medical applications that is supplied by Whitford or otherwise obtained from Whitford or from any of Whitford's customers.
No person has been authorized to give any information or to make any representations concerning the use of Whitford coatings and materials in medical applications (other than the information contained in or provided pursuant to this policy statement) and, if given or made, such information or representations must not be relied upon as having been authorized by Whitford.