Plastikos, Inc. Receives ISO 13485 Medical Device Certification


ERIEPlastikos, 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 early 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’ Manufacturing Manager Rob Cooney stated, “Becoming ISO 13485 certified will allow Plastikos to become better aligned with our medical customers in terms of documentation, employee training records, and internal process control. We have had the procedures in place for a number of years, so officially attaining ISO 13485 will allow us to better serve our medical customer base.”

Additionally, Plastikos’ attainment of its ISO 13485 certificate will enable Plastikos & Micro Mold to venture into new areas of medical device manufacturing that its Team has been exploring with a number of key medical device accounts.

Plastikos and sister company Micro Mold specialize in precision mold design and fabrication as well as tight-tolerance injection molding. Primary fields of expertise relating to plastic manufacturing include: medication delivery systems, surgical eye care, microfluidic, and electronic connector, among others.

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