Regulatory Compliance and Quality Assurance Support

The contract provides consulting support for regulatory compliance, quality system audits, and documentation activities essential to the delivery of a Class III medical device to the Department of Veterans Affairs. The work focuses on ensuring adherence to FDA requirements throughout the device’s development and delivery lifecycle, with particular emphasis on maintaining robust quality management systems and producing compliant technical documentation. This support is critical for meeting the stringent regulatory standards applicable to high-risk medical devices and facilitating successful procurement by the VA. The contract is classified as a subcontract under NAICS code 541611, which corresponds to management consulting services, and is administered by the Network Contract Office 23 under the Department of Veterans Affairs. While specific performance location and point of contact details are not provided, the scope is clearly defined around compliance and quality assurance activities tied to a Class III device, indicating a high level of regulatory scrutiny and technical precision. The posting date indicates the opportunity was made available in May 2026, with no set-aside provisions identified, suggesting it is open to any qualified subcontractor capable of meeting the federal regulatory demands of the procurement.