ISO 13485 certification plays role in expansion effort

January 30, 2009, Medical Design

PMC Medical’s recent registration to ISO 13485:2003 is one in a series of strategic steps to continue its growth in the medical device market, according to the Cincinnati-based company. “As a supplier into the implantable biomaterials and surgical device markets, ISO 13485 certification is a requirement to meet customer expectations,” says PMC President and fourth-generation Owner Lisa Jennings.

ISO 13485 certification is the fifth quality system that PMC (pmcsmartsolutions.com) has implemented and maintained with a perfect record. Registration comes on the heels of a $2 million-plus investment in its medical business over the past two years, including expansion with a state-of-the art clean room and all-electric Milacron Roboshot presses.

PMC’s contract manufacturing services include design for manufacturability, injection molding, assembly and packaging, and sterilization management.