4/30/2019

Plastikos Inc. Obtains Certification of Compliance

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Plastikos, Inc. announces that it officially obtained its certification of compliance with the ISO: 13485 Quality Management Systems for Medical Devices.

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Plastikos, Inc., a precision medical injection molder headquartered in Erie, PA, announces that it officially obtained its certification of compliance with the ISO: 13485 Quality Management Systems for Medical Devices on April 14, 2019. The ISO: 13485 standard builds upon the ISO: 9001 quality management system and incorporates numerous additional requirements for medical companies.

The ISO: 13485 certification comes at a time as the company 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. Later this month, the company will install five brand new medical injection molding machines, all of which are equipped with integrated three-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.

Additionally, the ISO: 13485 certificate will enable the company to better serve medical customers through documentation, employee training records and internal process control, as well as venture into new areas of medical device manufacturing.

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