“Demonstrates Unwavering Commitment to Quality” for Company’s Medical Devices
PITTSBURGH, PA, USA (May 4, 2009) –Neuro Kinetics, Inc. (NKI) (www.neuro-kinetics.com), manufacturers of noninvasive medical evaluation equipment used worldwide to test for balance, vestibular, neurological and other disorders, said today that it has earned the ISO 13485 certification for its nystagmography-based products and services.
Nystagmography is the recording and measurement of movements of eyeballs, and is the core of Neuro Kinetics’ products and services.
The quality management certification for medical devices was awarded by the Swiss-based International Organization for Standardization after on-site inspections of Neuro Kinetics’ manufacturing facility by Cermet, certified ISO auditors.
“We are delighted to earn this important designation,” said Joseph Argyros, Neuro Kinetics vice president, operations. “It demonstrates our unwavering commitment to quality in every step of our manufacturing processes.”
Howison Schroeder, Neuro Kinetics CEO, added that the ISO 13485 certification will help the company as it continues to expand the clinical utility of its products.
“We’ve set ambitious goals for extending the clinical utility of the tests that can be conducted on our devices. The mission is to give more clinicians the ability to noninvasively test and diagnose a wider range of diseases and conditions.”
Schroeder noted that in recent months a number of military medical facilities have installed Neuro Kinetics equipment to test returning combat soldiers for hard-to-detect mild traumatic brain injuries using Neuro Kinetics’ vestibular test batteries. Neuro Kinetics also is continuing its research in testing for early diagnosis of diabetic retinopathy.
“We see a number of promising clinical applications for our nystagmographic tests,” Schroeder. “As we reach out to more clinicians around the world, the ISO 13485 certification will be an important platform on which to build.”
Buckman Communications, for Neuro Kinetics, Inc.
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