Class III Medical Device Manufacturing and Supply

The contract involves the manufacture and supply of a heart implant medical device that meets stringent FDA Class III regulatory standards. This includes comprehensive design validation to ensure the device's safety and efficacy, sterile production processes to maintain product integrity, and full regulatory compliance to meet federal requirements. The contract is a subcontract issued by the Department of Veterans Affairs under the 261-NETWORK Contract Office 21. The scope of work focuses on producing a highly specialized medical device classified under NAICS code 339113, which pertains to surgical appliance and supplies manufacturing. While specific location details and points of contact are not provided, the commitment to rigorous quality control, adherence to regulatory procedures, and reliable supply of this life-saving heart implant device are central to the contract’s objectives. This initiative underscores the importance of delivering advanced medical technologies to support veteran healthcare.