Regulatory and Quality Compliance Support

The contract seeks regulatory and quality compliance support services focused on ensuring adherence to FDA 510(k) premarket notification requirements, Good Manufacturing Practices, labeling regulations, and Department of Defense DLA technical specifications. The vendor will be responsible for preparing and submitting comprehensive data packages necessary for regulatory approval, with an emphasis on medical devices destined for military use. Work will involve thorough documentation, technical evaluation, and coordination to meet the stringent standards required by both federal health authorities and defense logistics agencies. Performance of the contract is designated to occur at FPO, with a zip code of 96672-4090, and the solicitation is classified as a subcontract under NAICS code 541690 for other scientific and technical consulting services. The opportunity was posted on July 12, 2026, and responses must be submitted by July 20, 2026. The contracting entity is the Department of Defense through its Medical Supply Chain MD Surg FSF office, indicating this support is critical for equipping military medical units with compliant and properly documented medical devices. All deliverables must align with the technical, quality, and regulatory frameworks imposed by the defense supply chain and FDA standards.