Regulatory & Quality Compliance Support

The contract seeks support for regulatory and quality compliance activities to meet U.S. Food and Drug Administration requirements for Class II medical devices, with a focus on establishment registration, device listing, and adherence to Good Manufacturing Practices. This subcontract is part of a broader effort by the Department of Defense’s Medical Supply Chain to ensure that medical devices are properly documented, manufactured under compliant conditions, and fully aligned with federal regulatory standards. The work will involve maintaining accurate and up-to-date regulatory submissions, ensuring ongoing GMP compliance, and supporting quality systems throughout the device lifecycle to facilitate FDA approval and market access. The solicitation was posted on July 30, 2026, with a response deadline of August 5, 2026, and falls under NAICS code 541611 for Management, Scientific, and Technical Consulting Services. Although the contract does not specify a set-aside type or a designated point of contact, it is intended to be performed under the authority of the Department of Defense and will likely require experience in federal medical device regulation, prior engagement with FDA processes, and demonstrated capability in supporting Class II medical device programs. All work must align with agency standards for quality and compliance, and the successful contractor will be expected to integrate seamlessly with the existing regulatory and supply chain infrastructure of the Department of Defense.