CORAVIE MEDICAL INC

CORAVIE MEDICAL INC specializes in the design, development, and manufacturing of advanced medical devices and diagnostic equipment, leveraging its expertise in precision engineering and regulatory-compliant production processes. As a Women-Owned Small Business certified under the SBA’s 8(a) program and designated as a Woman-Owned Business, the company brings a strong commitment to innovation and quality assurance in high-stakes healthcare environments. Their technical capabilities include embedded systems development, biocompatible materials engineering, FDA 21 CFR Part 820 QSR compliance, and electromagnetic compatibility testing for Class II medical devices. CORAVIE’s specialization in low-volume, high-precision manufacturing enables tailored solutions for diagnostic imaging subsystems, patient monitoring interfaces, and point-of-care instrumentation, with a focus on reliability and traceability throughout the product lifecycle. Award history is not available to determine specific agency engagements or project types, limiting the ability to characterize direct federal partnerships. However, given its NAICS classification under 334510—Medical Equipment and Supplies Manufacturing—the company is positioned to support federal health, defense, and veterans’ care systems through the delivery of clinically validated, FDA-cleared hardware. The firm operates within the medical device manufacturing vertical, with core competency in translating clinical requirements into validated, ISO 13485-aligned production systems. Its market positioning emphasizes niche, high-integrity components for critical care and diagnostic applications, distinguishing itself through rigorous documentation control, design validation protocols, and supply chain transparency. CORAVIE MEDICAL INC is a small business headquartered in Minneapolis, Minnesota, structured as a 2L entity under SBA size standards. The company holds active Women-Owned Small Business and Woman-Owned Business certifications, enhancing its eligibility for set-aside contracts in federal healthcare procurement. Its geographic presence supports regional federal medical facilities and defense medical logistics networks, with a focus on delivering compliant, domestically sourced medical technology solutions.