Medical Device Manufacturing & Assembly

The contract involves the manufacture and assembly of fecal containment devices known as Flexi-Seal SIGNAL FMS, with full responsibility for quality control, packaging, and labeling in strict adherence to medical device regulatory standards. All work must be performed to ensure compliance with applicable FDA and ISO requirements, maintaining the highest levels of product integrity and safety for clinical use. The project requires precise processes for production, documentation, and traceability to meet the stringent demands of the medical device industry. The contract is classified as a subcontract under NAICS code 325620 and is managed by the Department of Defense through its Medical Supply Chain FSH entity. Performance is specifically required at Fort Bliss, Texas, with a zip code of 79918-2527. The solicitation was posted on July 28, 2026, and responses must be submitted by August 4, 2026, indicating a narrow two-week window for proposal submission. Participation is limited to qualified manufacturers capable of fulfilling all technical, logistical, and regulatory obligations outlined in the requirements.