Techmer PM has added ISO 13485:2016 certification for medical device and quality management systems at its site in Batavia, Illinois.
The Clinton, Tennesse-based company has been working on gaining this certification since fall 2021, according to William Reynolds, market manager for healthcare.
This certification offers a time-saving shortcut to Techmer’s healthcare customers, Reynolds noted, because with that ISO standard met, “our customers should be able to accept our outgoing quality certifications as their incoming quality certifications,” he says
CEO Michael McHenry added: “With more than 40 years of designing material solutions with brand owners, obtaining ISO 13485 certification completes a key initiative in executing our strategy and reinforces our corporate goals of continuous improvements and creating safe formulations for the medical device industry.”
This latest achievement continues the firm’s expanded efforts to serve the healthcare sector. While Techmer PM already had a robust portfolio of materials for that market, “this just gives our customers an added layer of assurance and support for increasing speed to market,” says Steve Loney, the firm’s director of marketing. “It will also make audits go more smoothly.”
In April, at the MD&M West trade show in Anaheim, California, Techmer PM introduced its new “HC” brand for medical devices and healthcare applications. “These materials leverage our proven technologies in both engineered compounds and masterbatch,” Loney said at the time. The expanded HC portfolio––which Techmer intends to produce entirely at the Batavia plant––relies upon a full palette of ISO 10993 or USP Class VI compliant pigments and additives to accelerate the development of customized healthcare products.
Reynolds says that Techmer PM has another key advantage in the market. It can leverage its thin-film and synthetic fiber dispersions, thereby allowing for the lightweighting and downgauging of medical components to help support its customers’ sustainability goals, all while maintaining the necessary physical properties.
