ISO 13485:2016 Certification
Pacific Plastics Injection Molding (PPIM), a division of Diversified Plastics, Inc. (DPI), is proud to announce that it has achieved ISO 13485:2016 certification for the medical device industry. ISO 13485 certification is part of the company’s growth initiative to meet the increased demand for medical device contract manufacturing.
ISO 13485:2016 is an international standard that details the requirements for a quality management system (QMS) specific to the medical device industry. To become ISO 13485 QMS certified, best practices in each step of a product’s life cycle must be demonstrated through quality management processes, including manufacturing, service and delivery.
“It is a testament to PPIM’s commitment to the highest safety and quality standards for medical device contract manufacturing,” says Pablo Soto, quality manager at PPIM. “Earning ISO 13485:2016 certification is a valuable achievement,.”
Planned during the company’s 2021 expansion, PPIM is in preparation for the installation of a 1,500-square foot cleanroom for plastic injection molding as well as a white room for assembly and packaging. Combined, the DPI facility in Minnesota and the PPIM facility in California total 99,000 square feet. The Minnesota location also has two ISO Class 8 cleanroom (Class 100,000)—one for micro injection molding.
PPIM and DPI have experience working with various medical-grade resins, including, but not limited, to PEEK, Ultem, polypropylene, polycarbonate and ABS. They include low- to large-volume production of endoscopes, pulse oximeters, surgical suture delivery devices, tabletop vital monitors, X-ray housings, wearable devices and more. The quality departments in both locations are well-informed in FDA 21 and CFR 820 specifications, which include IQ, OQ, PQs and other validation requirements.
For more information or to request a quote, call +1 760-598-5333 or visit www.pacificplastic.com. You can also download PPIM’s tool transfer white paper by visiting www.pacificplastic.com/resources.
