Whitford Corp., a manufacturer of fluoropolymer coatings for industrial and consumer industries, has announced the formation of a medical coatings group dedicated to supporting the use of its coatings on medical devices. Based at the company headquarters in Elverson, PA, the operation will occupy a newly constructed facility that is expected to be fully operational by Q3 2015.
Approximately 2% of Whitford's global sales currently involve medical coatings, Dave Willis, founder and CEO, told PlasticsToday, but he sees opportunities in that market that he hopes to tap into with the establishment of this group. "Though our coatings have been used on medical devices for many years, it was never a core business, and not one we aggressively pursued," said Willis. "We are changing our handling of medical coatings to provide a higher standard of service and quality controls and will now directly support medical device manufacturers with product development activities and specific quality control tests and certifications."
As part of this program, Whitford will implement an ISO 13485–compliant quality system, validating all levels of manufacturing and enhancing 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. "Complying with this international standard will allow us to meet global regulatory requirements."