Regulatory and Quality Compliance Support

The contract seeks specialized regulatory and quality compliance support to ensure an imaging table complies with FDA, CE, and ISO 13485 standards, focusing on the preparation of a comprehensive technical file and achieving audit readiness. The scope includes detailed documentation development, process alignment with international medical device regulations, and ongoing consulting to maintain ongoing compliance throughout the product lifecycle. All deliverables must meet the rigorous requirements of global regulatory bodies to facilitate market access and certification. The work is to be performed in Cheyenne, Wyoming, under a subcontract arrangement by a vendor responding to the Department of Veterans Affairs through its Network Contract Office 19. Proposals are due by August 4, 2026, and the effort falls under NAICS code 541611, which classifies it as management, scientific, and technical consulting services. While no set-aside designation is specified, the solicitation is open to qualified subcontractors capable of delivering regulatory expertise in the medical device sector, with a clear emphasis on technical documentation accuracy and operational readiness for third-party audits.