Winner of the MTEC 2020 Prototype of the Year Award, 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 span the pre-hospital, hospital, and military environments. The FDA-registered small business employs an iterative development methodology focused on human factors engineering to rapidly advance products. Critical Innovations LLC has strengths in medical device, software, and therapeutic development, including experience with: -Laboratory, preclinical, and clinical research -Cost, reimbursement, intellectual property, and market analysis -FDA quality system regulations -Rapid prototyping -Manufacturing set-up and transition -Unique challenges to military systems, environments, and program management