Prototype Manufacturing & Assembly (Low-Volume Production)

The contract requires the manufacture and assembly of low-volume prototype units for the ACLCMV system, specifically tailored for testing, demonstration, and enabling studies related to IDE submissions. Work must adhere to strict design controls and quality assurance protocols, with comprehensive documentation to ensure traceability and regulatory compliance throughout the production process. The effort centers on delivering functional prototypes that meet technical specifications for evaluation purposes, with a focus on precision, reliability, and reproducibility in a controlled manufacturing environment. Performance is designated to take place in Frederick, Maryland, with a submission deadline of July 15, 2026. The contract is structured as a subcontract under the Defense Health Agency, part of the Department of Defense, and falls under NAICS code 339113 for medical equipment and supplies manufacturing. Although no set-aside classification or point of contact details are specified, the work is critical to advancing medical device development within a federal regulatory framework, emphasizing rigorous quality control and adherence to industry standards for prototype validation.