Regulatory Compliance and Documentation Support

This contract supports regulatory compliance and documentation efforts related to FDA Unique Device Identification (UDI) requirements and VA medical device recordkeeping, ensuring alignment with federal standards for medical device tracking and reporting. The work involves integrating internal tracking systems with existing VA infrastructure to maintain accurate, auditable device lineage and compliance records, with a focus on streamlining data flow and minimizing regulatory risks. The contract is a subcontract set aside specifically for Service-Disabled Veteran-Owned Small Businesses and falls under NAICS code 541611, indicating it involves administrative management and general management consulting services. It is administered by the Department of Veterans Affairs through the 261-NETWORK Contract Office 21, with performance expected to be conducted wherever the contractor’s operations are based, as no specific location is defined. The contract was posted in April 2026 and is intended to enhance the VA's ability to meet federal medical device surveillance and traceability obligations.