Regulatory Compliance and Quality Assurance Consulting

This contract involves providing specialized consulting services focused on regulatory compliance and quality assurance for medical device supply to federal agencies, specifically supporting the Department of Veterans Affairs under the Nac Federal Supply Schedule. Key responsibilities include assisting with FDA submissions, conducting quality system audits in accordance with the Quality System Regulation (QSR), ensuring compliance with ISO 13485 standards, and managing essential documentation related to medical devices. The scope of work ensures that devices meet stringent federal requirements, facilitating their approval and supply to government entities. The contract is classified under the NAICS code 541611, which pertains to administrative management and general management consulting services. Although specific details such as solicitation number, set-aside types, and exact place of performance are not provided, the subcontract aims to support federal medical device regulation processes by leveraging expertise in regulatory frameworks and quality management systems. The contract was posted on June 5, 2026, underscoring its alignment with ongoing compliance needs within federal healthcare procurement programs.