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Plastikos secures ISO 13485 medical device certification

April 23, 2019 By Chris Newmarker

Plastikos medical molding
Plastikos had a topping off ceremony in October 2018 for its new medical molding building, a quarter mile from its Erie. Pa. headquarters. [Image courtesy of Plastikos]
Plastikos (Erie, Pa.) said today that it has obtained its certification of compliance with the ISO 13485 quality management systems for medical devices, effective April 14.

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.

Filed Under: Components, Injection Molding Tagged With: plastikos

About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

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