Regulatory and Compliance Support

The contract seeks a Service-Disabled Veteran-Owned Small Business to provide regulatory and compliance support for the procurement of the AngioJet system, specifically assisting the prime contractor with documentation, certification, and audit readiness related to FDA regulations, the Buy American Act, and the Trade Agreements Act. The work involves ensuring all necessary compliance materials are accurately prepared and maintained to meet federal procurement standards, with a focus on audit preparedness to validate adherence to statutory and regulatory requirements. The subcontractor must be capable of navigating complex medical device procurement rules and delivering timely, precise compliance outputs aligned with federal contract obligations. Performance is required to occur in Lebanon, Pennsylvania, with a submission deadline of August 14, 2026, and the opportunity is set aside exclusively for Service-Disabled Veteran-Owned Small Businesses under FAR 19.14. The North American Industry Classification System code is 541611, indicating the scope involves administrative management and general management consulting services, specifically tailored to regulatory affairs and government compliance functions. The contracting office is the Department of Veterans Affairs’ 244-NETWORK Contract Office 4, underscoring the federal nature and mission-critical focus of the engagement, where accurate compliance is essential to ensure lawful and uninterrupted procurement of medical equipment for VA healthcare delivery.