BETHESDA, Md.--(BUSINESS WIRE)--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.
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