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Critical Innovations LLC is an ISO 13485:2016 certified, 21 CFR§820 QSR and DCAA compliant, medical research and development company focused on creating cutting-edge solutions to health threats that the span pre-hospital, hospital, and military environments. The FDA-registered small business employs an iterative development methodology focused on agile engineering to rapidly advance products. The company has received its California Medical Device Manufacturing License issued by the Department of Public Health’s Food and Drug Branch (CDPH License #119137). Critical Innovations has the latest in professional CAD software, additive manufacture, bread-boarding, machining, and other equipment to rapidly prototype a wide range of medical products. Critical Innovations’ facility possesses a host of in-house manufacturing capabilities, including an ISO 7 clean room. Testing capabilities include human simulators and a complete internal lab. To the best of our knowledge, our facilities meet all
applicable federal, state, and local environmental laws and regulations.

CD010 Rev.M 2024-06-20

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