Plastikos Receives ISO13485 Medical Devices Certification


Plastikos, Inc., a precision medical injection molder headquartered in Erie, Pennsylvania, recently announced that it officially obtained its certification of compliance with the ISO 13485 Quality Management Systems for Medical Devices. The ISO 13485 standard builds upon the ISO 9001 quality management system and incorporates numerous additional requirements for medical companies.

Philip Katen, Plastikos’ president and general manager commented, “Plastikos’ attainment of our ISO13485 certificate represents a major milestone accomplishment for our team in direct support of our medical OEM customers. Our team’s ISO:13485 certification effort was one that required strategic planning along with countless hours and hard work over the past few years to attain, and which ushers in the next chapter of our company history as a growing, world-class 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.”

Obtaining the ISO 13485 certificate is perfect timing as Plastikos continues to experience strong cleanroom medical molding growth. The construction of its brand new medical facility, Plastikos Medical, is projected to be completed this summer.

Plastikos’ team will install five brand new medical injection molding machines, all of which are equipped with integrated 3-axis robotics and cavity pressure monitoring systems in order to be production-ready as soon as the new medical facility is complete. The new facility will be large enough to accommodate 10 molding machines with future provisions to further expand the facility to 20 cleanroom molding machines.

Plastikos and sister company Micro Mold specialize in precision mold design and fabrication, as well as tight-tolerance injection molding.

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