Regulatory Compliance and Quality Assurance Support

The contract seeks consulting support to ensure regulatory compliance with the FDA’s Quality System Regulation, ISO 13485 quality management standards, and Veterans Affairs procurement requirements for medical device suppliers. This subcontract focuses on providing expert guidance to help contractors navigate the complex regulatory landscape governing medical device manufacturing, documentation, and supply chain adherence specific to VA acquisition protocols. The work will involve assessing current quality systems, identifying gaps, implementing corrective actions, and ensuring ongoing alignment with applicable federal and international standards. The contract is associated with the Department of Veterans Affairs through its 261-NETWORK Contract Office 21 and falls under NAICS code 541611 for management consulting services. Performance of the services is not tied to a specific location, allowing for flexibility in remote or on-site support as needed. The solicitation was posted on August 6, 2026, and is structured as a subcontract, indicating it will be awarded under a prime contract to support broader VA medical device procurement objectives. The goal is to strengthen supply chain reliability and regulatory compliance for medical devices used within the VA healthcare system.