FDA Regulatory Compliance & Technical Documentation Support

The contract requires comprehensive regulatory strategy and technical documentation support for Class II medical device components, including preparation and submission assistance to the FDA, development of labeling compliant with U.S. regulations, and ongoing maintenance of technical files to ensure continuous regulatory alignment. The scope encompasses end-to-end regulatory activities needed to meet FDA requirements, with emphasis on accurate and up-to-date documentation that supports device clearance and market sustainability. All deliverables must adhere to current regulatory expectations and be executed with precision to avoid non-compliance risks. The contract is issued under the NAICS code 541690 as a subcontract by the Department of Veterans Affairs through the 262-NETWORK Contract Office 22 and is performance-based in Long Beach, California, with the response deadline set for July 15, 2026. The work supports critical medical device programs and requires deep expertise in FDA regulatory pathways, labeling standards, and technical file management. Subcontractors must demonstrate proven experience in supporting Class II medical devices and maintaining compliance through dynamic regulatory environments.