NeuroWave Systems Inc. receives ISO 13485:2003, CMDCAS and MDD 93/42/EEC certifications

CLEVELAND HEIGHTS, Ohio (September 2010) - NeuroWave Systems Inc. announced that the company has achieved ISO 13485:2003 certification of its Quality Management System for the design and manufacture of safe and effective medical devices in September of 2009. BSI Management Systems, one of the world′s leading certification bodies, also certified NeuroWave to the requirements of the Canadian Medical Device Conformity Assessment System and European Medical Device Directive 93/42/EEC, later being required to place the CE mark on company’s products. These certifications allow NeuroWave to distribute its products to the large markets of European Community, Canada and a number of other countries in order to strengthen its worldwide market presence.

Globally recognized, ISO 13485 standards are set by the International Organization for Standardization, a Geneva-based worldwide federation comprised of national standard bodies representing 158 of the 195 total countries in the world. ISO works in partnership with international organizations, governments, industry, business and consumer representatives to establish the standards by which best in class organizations are measured and perform.

NeuroWave develops advanced brain monitoring technologies for applications in anesthesia and neurology, based on leading-edge signal processing of noninvasive brain waves. Tracie Capozzio, who leads NeuroWave's quality assurance and regulatory compliance, notes: "We take tremendous pride in the fact that NeuroWave Systems is pioneering highly sophisticated medical devices that are designed and manufactured in accordance with the strictest quality assurance practices. To demonstrate and confirm this, we underwent an intensive series of audits designed to ensure that our internal quality control and assurance processes throughout our organization conform to ISO certification standards. Every procedure and results of these were vigorously reviewed and evaluated to assure compliance."

"Undergoing the rigorous medical device certification is a testament of NeuroWave’s commitment to improving patient outcomes and quality of life through providing the highest quality medical devices" stated Tatjana Zikov, NeuroWave's President. "This milestone also secures our persistent excellence and growth. Moreover, it allows us to bring the benefits of our pioneering brain monitoring technologies to the patients worldwide."

About NeuroWave:
NeuroWave System Inc.'s mission is to develop, manufacture, and market monitoring products using advanced signal processing of brain waves (electroencephalogram - EEG) and other biosignals for Anesthesia, Neurology, Emergency Medicine and Psychiatry applications, in order to improve patient outcome and quality of life.