Quality Assurance & Regulatory Compliance Support

The contract seeks a third-party provider to perform quality assurance and regulatory compliance support for spinal fusion implants, ensuring adherence to FDA regulations, ISO 13485 quality management standards, and ASTM testing specifications. The scope includes comprehensive validation activities such as design verification, process validation, and analytical testing to confirm product safety and performance, along with full documentation support necessary for regulatory submissions and audits. The vendor will be expected to collaborate closely with the contracting entity to maintain compliance throughout the product lifecycle, providing detailed reports, test data, and evidence of conformity to international and U.S. medical device requirements. The work is structured as a subcontract under the Department of Veterans Affairs through the 250-NETWORK Contract Office 10, classified under NAICS code 541380 for other scientific and technical consulting services. Performance is not tied to a specific physical location, allowing for flexible, remote or on-site execution as required by the validation tasks. The solicitation was posted in June 2026, indicating a forward-looking procurement timeline, and is open to qualified entities capable of delivering specialized regulatory and technical expertise in the medical device sector without set-aside restrictions. The focus remains on rigorous, evidence-based compliance to enable market access and continued use of spinal fusion implants in VA healthcare settings.