Regulatory Compliance and Quality Assurance Support

The contract provides ongoing regulatory support to ensure compliance with FDA requirements for 510(k)-exempt medical devices, covering critical areas such as device registration, labeling adherence, current good manufacturing practices, and audit preparedness. The scope is designed to maintain continuous regulatory standing and operational readiness, ensuring that all aspects of quality assurance align with federal standards without the need for premarket notification. This subcontract is issued under the Defense Logistics Agency, part of the Department of Defense, with a NAICS code of 541611 indicating professional, scientific, and technical services related to regulatory affairs. The contract was posted on July 17, 2026, and is tied to the procurement identifier SPE2DH26P1012. While specific performance locations and point of contact details are not provided, the work is expected to support the agency’s mission-critical medical device supply chain through sustained compliance and quality infrastructure.