FDA Compliance & Regulatory Attestation Services

This contract seeks specialized services to support regulatory compliance for health IT software tied to FDA Class I medical devices, including assistance with self-attestation processes and the preparation of audit-ready documentation packages. Where applicable, it also requires the development of 510(k) submission materials to ensure alignment with FDA regulatory expectations. The contractor will be responsible for assembling comprehensive, defensible compliance records that meet rigorous audit standards, focusing on the unique requirements of medical device software under federal oversight. The opportunity is categorized as a subcontract under NAICS code 541611 and is managed by the Department of Veterans Affairs through the 262-NETWORK Contract Office 22. Performance is expected to take place in San Diego, California, with a response deadline of July 14, 2026, at 3:00 PM. The solicitation was posted on June 26, 2026, and is open for bids from qualified organizations capable of delivering regulated health IT compliance services with precision and adherence to current FDA guidelines.