Regulatory and Compliance Support for Medical Device Supply

The contract seeks regulatory consulting services to ensure full compliance with FDA, Department of Defense, and Federal Acquisition Regulation requirements for medical device labeling, hazardous materials reporting, and technical data submissions. The work is focused on supporting the Medical Supply Chain MD Surg FSF under the Department of Defense, with performance required at FPO, zip code 09592-4500. The subcontract is intended to provide expert guidance in navigating complex regulatory frameworks specific to medical devices distributed through defense channels, ensuring that all documentation, packaging, and data submissions meet federal standards for safety, traceability, and reporting. The opportunity was posted on July 14, 2026, with a response deadline of July 20, 2026, and is classified under NAICS code 541690 for other scientific and technical consulting services. While no set-aside designation is specified, the nature of the work implies a requirement for specialized knowledge in defense and medical regulatory environments. Contractors must demonstrate proven experience in interfacing with both FDA and DoD compliance systems, particularly in the context of fielded medical equipment, hazardous substance disclosures, and controlled technical data handling. All deliverables must be aligned with the agency’s operational and logistical needs within the military supply chain.