Medical Device Supply – Heart Valves

The contract entails the procurement and delivery of FDA-compliant heart valves for clinical use at the Louis Stokes Cleveland VA Medical Center, ensuring all devices meet stringent regulatory standards for patient safety and efficacy. The prime contractor is responsible for the full lifecycle of the product including manufacturing, quality assurance testing, proper packaging, and timely shipment, with no reliance on third parties for critical phases of production or compliance verification. All valves must be manufactured under FDA-approved protocols and certified for implantation in human patients, adhering to current medical device quality systems and regulatory requirements. Delivery is strictly for use within the VA facility, targeting cardiac patients requiring valve replacement, and the contractor must ensure complete traceability, labeling, and documentation aligned with federal healthcare procurement guidelines. Though solicitation details are unspecified and the contract is classified as a subcontract under NAICS code 339112 for Surgical and Medical Instrument Manufacturing, the obligating agency is the Department of Veterans Affairs through the 250-NETWORK Contract Office 10. The contract was posted in June 2026 and requires full compliance with VA medical supply protocols, including handling, storage, and documentation to support clinical deployment without delays or regulatory interruptions.