Compliance and Regulatory Consulting (FDA, HIPAA, AATB)

The contract seeks regulatory consulting services to ensure full compliance with FDA 21 CFR Parts 820 and 830, HIPAA, The Joint Commission, AATB, and ISO 9001 standards, with a focus on validation processes, comprehensive documentation, and audit readiness support. The work is intended to assist the Department of Veterans Affairs in maintaining rigorous quality and regulatory controls across medical device and health information systems, requiring expert guidance to meet the layered requirements of federal and industry-specific regulations. The consultant will be expected to provide actionable strategies for continuous compliance, identify gaps in current systems, and implement solutions that align with evolving regulatory expectations. This subcontract is posted under the NAICS code 541611 for Management Consulting Services and is managed by the Network Contract Office 19 within the Department of Veterans Affairs, with performance required in Salt Lake City, Utah, 84148. The solicitation was made available on July 22, 2026, and responses are due by August 5, 2026, at 11:00 PM. Although no set-aside designation or point of contact is specified, interested parties are directed to the SAM.gov portal for further details and submission requirements. The scope demands a high level of technical expertise in life sciences and healthcare regulatory frameworks, with an emphasis on practical, sustainable compliance outcomes.