Regulatory Compliance and Quality Documentation

The contract requires the preparation and ongoing maintenance of regulatory compliance documentation for a Class I medical device under 21 CFR 880.690, including FDA registration, proper labeling, GMP records, and all necessary quality assurance materials. This work must be performed in strict adherence to federal regulations to ensure the device meets all applicable standards for safety, efficacy, and marketability within the U.S. healthcare system. The subcontractor is responsible for managing the full lifecycle of compliance documentation, with an emphasis on accuracy, timeliness, and audit readiness. The solicitation is issued under the NAICS code 541611 for management consulting services and is linked to the Department of Defense through the Medical Supply Chain FSH office, with performance located at Fort Bragg, North Carolina, zip code 28310. The opportunity was posted on July 27, 2026, and responses are due by August 3, 2026. Although no set-aside designation is specified, the nature of the work suggests it is intended for vendors with proven expertise in medical device regulatory affairs and quality systems within federal supply chains. All deliverables must align with Department of Defense requirements and be maintained to support inspections, audits, and continuous regulatory compliance.