FDA Regulatory Compliance and Submissions Support

This contract entails ongoing support for regulatory compliance with the FDA for Class I medical devices, covering critical activities such as device registration and listing, labeling adherence to federal requirements, and sustained compliance with Good Manufacturing Practices. The scope includes ensuring audit readiness through meticulous documentation management and maintaining all necessary records to demonstrate continuous compliance with FDA standards. The work is performed at Fort Stewart, Georgia, with a response deadline of August 17, 2026, and is issued as a subcontract under a Department of Defense procurement managed by the Medical Supply Chain MD Surg FSF. The North American Industry Classification System code 541611 indicates this is a professional, scientific, and technical service focused on administrative management and regulatory compliance support. All deliverables are expected to align with U.S. regulatory frameworks without reliance on external documentation references.