The Performance Plastics/Consumer Essential Markets (CEM) business of Trinseo (Berwyn, PA), a manufacturer of plastics, latex binders and synthetic rubber, announced that it has received ISO 13485 certification. The international standard sets forth the requirements of a quality management system for the design and manufacture of medical devices.
ISO 13485 certification increasingly has become a de facto requirement for serious-minded suppliers to medical device OEMs. Back in 2015, I asked a number of contract manufacturers and molders serving the medtech industry whether the cost and headaches of certification were worth it. Absolutely, almost all of them replied. "ISO 13485 is the biggest precursor for entering the medical molding market. The standard dictates a consistent, methodical approach. I don't see how you can expect to be taken seriously without it,” said Timothy Reis, Vice President, Healthcare Business Development, at GW Plastics (Bethel, VT).
|Visit Trinseo at booth 538 and walk the show floor to discover innovations throughout the plastics supply chain at the co-located MD&M West and PLASTEC West events in Anaheim, CA, on Feb. 7 to 9, 2017. For more information and to register to attend, go to the PLASTEC West or MD&M West website.|
For Trinseo, certification provided a well-defined path to greater alignment with its customers. “In order to be a true partner to our medical device customers, we wanted to take the extra step and get ISO 13485 [certification] so our business approach and thought processes could be completely aligned,” said Philippe Belot, Business Director of Trinseo’s CEM business. “Quality and risk management are extremely important in this industry and a mutual commitment to a standard such as ISO 13485 makes it much easier to work together, ensure quality output and reduce the risk of non-compliance.”
ISO 13485 challenges organizations to place a greater focus than other standards on risk management and process validation, notes Trinseo in its press release. Organizations need to determine how they can improve performance by looking at risk factors such as inventory levels, supply chain and facilities and implementing steps to analyze and measure processes rather than simply having processes in place, adds Trinseo.
The ISO 13485 certification applies to Trinseo’s facilities and functions involving the manufacture and production of medical compounds as well as global functions related to technical services and development, R&D, quality, sales and human resources. While ISO 13485 is specific to medical design and manufacturing, the standard’s processes and procedures apply to all Trinseo products being produced at the certified facilities.
In addition to medical devices, Trinseo serves automotive, consumer electronics, building and construction and other OEM customers from 15 manufacturing sites around the world. Generating approximately $4 billion in revenue, the company has a workforce of more than 2,200 employees.
The company is exhibiting at next month's co-located MD&M West and PLASTEC West trade shows in Anaheim, CA, at booth 538. Part of North America's largest annual design and manufacturing event, the trade shows and conference come to the Anaheim Convention Center on Feb. 7 to 9, 2017.