Cogmedix Successfully Passes ISO 13485:2016 Recertification Audit

Published: May 19, 2017

WORCESTER, Mass., May 18, 2017 /PRNewswire/ -- Medical device manufacturer Cogmedix is pleased to announce they recently passed an ISO 13485:2016 Recertification Audit. This places Cogmedix among the first companies in the industry to be fully certified in this new world-renowned quality standard for medical devices. ISO 13485:2016 is notable as the first major change to this standard in over 13 years.

"These audits are instrumental in our quality systems," said Vincent Kiedaisch, Director of Quality and Compliance at Cogmedix. "We continue to raise the bar and lead when it comes to quality and compliance in the medical device industry."

The recertification audit was completed over the course of two and a half days, under the full supervision of two professional auditors from TÜV SÜD. Throughout that time, the auditors were very complimentary about not only the Cogmedix facility, but also about the passion and expertise of the Caring Associates who work there and the quality systems they use each day.

"Pursuing successful certification to ISO 13485:2016 inclusive of all design and manufacturing activities ahead of the rest of the market shows we are leading the way," said Cogmedix Executive Vice President and General Manager, Matt Giza. "We take great pride in our company culture of compliance and continuous improvement and would like to thank all of our Caring Associates who assisted in this successful audit."

About Cogmedix

Cogmedix is a team of talented Caring Associates that brings OEM medical technology to life. Providing turnkey medical device manufacturing services to a broad range of medical and dental OEMs, Cogmedix delivers high quality products to market with compliance, competence and commitment. Cogmedix provides a high level of flexibility in product launch and demand management and aligns itself with innovative companies that maintain similarly high standards in honesty and integrity. Cogmedix is a subsidiary of Coghlin Companies, Inc., a privately held concept-to-commercialization firm spanning four generations. Visit Cogmedix and sign up for the e-Newsletter at

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SOURCE Cogmedix

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