BrainScope, a medical neurotechnology company, has been successfully certified to ISO 13485:2003, the international standard for comprehensive quality management systems for design and manufacture of medical devices.
ISO 13485:2003 is an international, globally recognized standard for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical device design and manufacturing.
In addition, compliance with ISO 13485 is also a necessary step in achieving compliance with international regulatory requirements such as the CE Mark. BrainScope was awarded certification by BSI, one of the world’s leading certification bodies.
BrainScope president and CEO Michael Singer noted that as a medical device company in the TBI and concussion space, ISO 13485 certification demonstrates the company’s commitment to operate in a systematic, predictable, and verifiable manner on behalf of its customers in the medical device market.
"This certification reflects the significant investment in, and organizational focus on, the quality systems and appropriate regulatory certifications required to manufacture and ultimately deliver products used by clinicians to make important neurological assessment decisions," Singer added.
In collaboration with the US Department of Defense and other partners, BrainScope has conducted six years of independent studies in hospital emergency departments, as well as in college and high school sports venues.
These studies have helped to develop a comprehensive database of over 4,000 brainwave recordings for the creation of sophisticated classification algorithms that quantify and characterize features of brain electrical activity associated with TBI.