Traumatic Brain Injury / Concussion Company Receives Certification for Medical Device Design and Manufacturing Quality Systems
BETHESDA, MD. April 14th, 2014 – BrainScope® Company, Inc., a medical neurotechnology company that is developing a new generation of hand-held, easy-to-use, non-invasive instruments designed as adjuncts to standard clinical practice assessment to aid medical professionals in rapidly and objectively assessing traumatic brain injury (TBI), today announced it 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.
"As a medical device company in the TBI and concussion space, ISO 13485 certification demonstrates our commitment to operate in a systematic, predictable, and verifiable manner on behalf of our customers in the medical device market," said Michael Singer, President and CEO of BrainScope. "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."
In collaboration with the U.S. 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.
Backed by Revolution (created by AOL co-founder Steve Case), Shaman Ventures, ZG Ventures, Maryland Venture Fund, Brain Trust Accelerator Fund, and Difference Capital, BrainScope is a medical neurotechnology company that is developing a new generation of hand-held, easy-to-use, non-invasive instruments designed as adjuncts to standard clinical practice assessment to aid medical professionals in rapidly and objectively assessing traumatic brain injury (TBI). BrainScope devices in development are based on a proprietary technology platform, which integrates databases of brainwave recordings with advanced digital signal processing, sophisticated algorithms using machine learning techniques, miniaturized hardware and disposable headset sensors. BrainScope's unique devices are being created to meet a long-standing clinical need for improved early identification, staging and triage of head injured patients. BrainScope devices under development for assessment of traumatically-induced head injury and concussion are for investigational use only. For more information, please visit www.brainscope.com.