Regulatory Compliance and Documentation Support

This contract provides regulatory compliance and documentation support for a medical device installed in a federal setting, specifically addressing requirements under the FDA, NRC, or state radiation control authorities. The scope includes preparing and maintaining all necessary compliance documentation, ensuring audit readiness, and coordinating licensing activities to secure and sustain operational authorization for the device. The work is critical to maintaining legal and regulatory alignment in a healthcare environment governed by strict radiation safety and medical device standards, with performance located in Portsmouth, Virginia, under a subcontract arrangement. The offering is tied to the Defense Health Agency within the Department of Defense and falls under NAICS code 541611 for administrative management and general management consulting services. All proposals must be submitted by July 29, 2026, at 7:00 PM ET, with bidding open to qualified subcontractors capable of delivering expert-level regulatory support in radiation-controlled medical environments.