Manufacturing of Blood Recipient Sets with Regulatory Compliance

The contract involves the manufacture of Class II medical devices specifically blood recipient sets that must meet stringent regulatory requirements, including FDA 510(k) clearance, ISO 13485 certification for quality management systems, and compliance with military packaging standards. This subcontract is issued by the Department of Defense under the Medical Supply Chain MD SURG FSF agency, with the place of performance specified as Fort Bragg, ZIP code 28310. The work falls under the NAICS code 325620, which pertains to the manufacture of medical and surgical instrument manufacturing. The solicitation was posted on May 18, 2026, with a response deadline set for May 26, 2026, providing interested manufacturers a short timeframe to respond. Although no solicitation number or set-aside information is provided, the contract’s focus on regulatory compliance highlights the critical need for adherence to strict quality and safety standards in producing blood recipient sets intended for military use. The subcontract aims to ensure that the medical devices supplied meet both civilian and military regulatory frameworks to support defense healthcare operations.