TAVR Device Manufacturing and Assembly

The contract encompasses the full-cycle manufacturing, assembly, and quality assurance of transcatheter aortic valve replacement (TAVR) medical devices, designed for use within Veterans Affairs medical facilities. This includes the integration of all component parts, precise assembly procedures, rigorous quality control measures, sterilization processes, and final packaging to ensure compliance with medical standards and readiness for clinical deployment. Every stage of production must meet stringent regulatory and performance requirements to guarantee patient safety and device reliability. The work is classified under NAICS code 339113, indicating specialization in medical equipment and supplies manufacturing, and is structured as a subcontract under the Department of Veterans Affairs through Network Contract Office 23. The contract is set to be posted on June 26, 2026, with performance expected to occur without a specified geographic limitation, implying that manufacturing and assembly activities may take place at the contractor’s facility or other approved sites, as long as delivery to VA facilities is fulfilled according to contractual timelines and standards. The nature of the work demands advanced technical expertise, adherence to FDA and ISO regulations, and robust traceability throughout the supply chain.