ISO 13485 Certification Granted to Techner PM’s QMS

Compounder and materials design firm Techmer PM has gained ISO 13485:2016 certification for its quality management systems at its Batavia, Ill., plant.
 
The Clinton, Tenn.-based company has been working on gaining this certification since fall 2021, according to William Reynolds, market manager for healthcare. 
 
Ultimately, this 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.”
 
CEO Michael McHenry stated: “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,” said Steve Loney, the firm’s director of marketing. “It will also make audits go more smoothly.”
 
In April, 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 said that Techmer PM 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.
 
The Batavia plant has already been ISO 9001-certified.
 
Founded in 1981, Techmer PM LLC is a materials design company specializing in modifying and fine-tuning the properties of technical polymers. The company thrives on collaborating with plastics processors, fabricators, designers, specifiers, and brand owners. Drawing on a broad portfolio of resins––from polyolefins to PEEK––Techmer PM helps manufacturers enhance product function and appearance in scores of end-use markets. The firm operates six North American plants and has extensive expertise in virtually every plastic- and fiber-related process, from additive manufacturing and blown film to nonwovens, injection molding, and sheet extrusion.