The ISO 13485 standard builds upon the ISO 9001 quality management system, with a host of additional requirements for medical device manufacturers.
Philip Katen, Plastikos’ president and general manager, described the certificate as a major milestone for the company, which is growing as a cleanroom medical molder. “And the strategic timing of our 13485 certification fits perfectly, as we now look forward to the opening of our brand new Plastikos Medical facility in just a few short months!” Katen said.
The new stand-alone medical manufacturing facility in Erie is slated for completion this summer. Later this month, Plastikos’ team will install five new medical injection molding machines, all equipped with integrated three-axis robotics and cavity pressure monitoring systems. The new facility will be large enough to accommodate 10 molding machines, and there are provisions to expand to 20 cleanroom molding machines in the future.