Project and Quality Management Planning

The contract requires the development and ongoing maintenance of comprehensive project and quality management deliverables for the full product development lifecycle under FDA oversight, including the Project Management Plan, Quality Management Plan, Integrated Management System, and Work Breakdown Structure. These documents must align with regulatory requirements and support the successful execution of health-related development initiatives under the Department of Defense’s Defense Health Agency. The work is to be performed primarily in Frederick, Maryland, with strict adherence to federal standards for quality and project governance in regulated environments. This subcontract opportunity is open for response until July 30, 2026, and is classified under NAICS code 541611, indicating it pertains to management consulting services. The effort is critical to ensuring compliance, traceability, and organizational efficiency throughout product development phases subject to FDA review and approval. Contractors must demonstrate experience in supporting regulated healthcare or defense medical projects, with established methodologies for managing complex documentation systems and cross-functional coordination under stringent regulatory constraints.