Regulatory Compliance & Quality Assurance for Medical Items

The contract requires strict adherence to FDA regulations, Good Manufacturing Practices, and Medical Marking Standard No. 1 for all medical items, ensuring full compliance with federal medical device standards. Key responsibilities include implementing robust lot traceability systems and precise expiration date management with a mandatory 60-month shelf life requirement, demanding rigorous documentation and quality control throughout the supply chain. All activities must maintain the integrity and safety of medical products from production through delivery. The solicitation is classified as a subcontract under NAICS code 541611, issued by the Department of Defense through the MEDICAL SUPPLY CHAIN MD SURG FSF office. Responses are due by July 22, 2026, and performance is expected to be carried out at FPO, with a zip code of 96672-4090. The contract emphasizes regulatory precision and operational accountability, targeting contractors capable of sustaining high standards for medical item quality and compliance under federal oversight.