REDCOM EMS expands certification for medical device manuf…



General | May 28, 2020

Editor: Lisa Lucke

New York-based REDCOM EMS has secured ISO 13485:2016 certification, complementing the company’s existing ISO 9001:2015 and AS9100D certifications.

The new certification became effective May 8 and was issued by TUV Rheinland, a certification body independent quality inspection services. Maintaining the certification will require comprehensive audits by the internal team and annual validation by a third-party certifying body.

In a press release, Steve Husband, VP of Manufacturing, REDCOM, and GM, REDCOM EMS, said about the certification, “As the need for medical equipment is more important than ever, REDCOM EMS is well positioned with the recent addition of the ISO 13485:2016 certification for our Quality Management System. With this additional certification, REDCOM EMS is pleased to offer our electronic manufacturing services to the medical device industry. This certification, along with the AS9100D:2016 and the ISO 9001:2015, is a true testament to our commitment of providing a quality product to a diverse customer base.”

With regard to Quality Engineer and Millennial in Manufacturing award winner Lauren Iuranich, who led the team in obtaining this certification, said, “This certification, in conjunction with the AS9100D certification we received last year, highlights our commitment to quality and delivering safe, mission-critical products to our customers.”


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