FDA Regulatory Compliance and Quality Assurance

The contract focuses on maintaining ongoing FDA regulatory compliance for medical devices, specifically ensuring the continued validity of 510(k) clearances, strict adherence to current Good Manufacturing Practices (cGMP), and maintaining comprehensive quality system documentation. It is positioned as a subcontract opportunity under the Department of Defense's Medical Supply Chain MD SURG FSF agency and is categorized under the NAICS code 541611, which pertains to administrative management and general management consulting services. The work is to be performed at a designated APO location with the ZIP code 09898. The contract was posted on May 19, 2026, with a response deadline of May 26, 2026. While specific details about set-asides or the contracting office’s physical address are not provided, the scope emphasizes ensuring that all regulatory and quality assurance requirements are systematically upheld to support medical device compliance. This positions the subcontractor in a critical role to support the Department of Defense’s supply chain by safeguarding the integrity and regulatory conformity of medical devices throughout their lifecycle.