Final Device Assembly and Sterilization

The contract requires the final assembly, quality inspection, sterilization, and packaging of the IT Clamp within a controlled cleanroom environment that meets both FDA 510(k) clearance requirements and applicable military standards. All processes must ensure compliance with stringent regulatory and operational benchmarks to guarantee product safety, efficacy, and readiness for use in medical and defense contexts. The work is to be performed at a designated location with a postal address of FPO, ZZ 96672-4090, indicating a military postal facility, and must adhere to the technical and procedural protocols necessary for medical device manufacturing under federal oversight. This is a subcontract opportunity under the NAICS code 325414, which classifies the activity as pharmaceutical and medicine manufacturing, and was posted on July 12, 2026, with a response deadline of July 20, 2026. The contracting entity is the Department of Defense through the Medical Supply Chain MD Surg FSF, highlighting the application of the IT Clamp in military medical operations. While the solicitation number is not provided, the official opportunity can be accessed via the DIBBS platform, and bidders must be prepared to demonstrate capability in sterile processing, regulatory compliance, and quality assurance aligned with both civilian health authorities and military logistical standards.