Criticalinnovations

About Criticalinnovations

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

• Medical device
• Medical software
• Medical theraputics
• Research
• development

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