Medical Device Manufacturing and Assembly

The contract involves the full manufacturing, assembly, and quality assurance of the V.A.M.P. Monitoring Set, a commercial off-the-shelf medical device designed for vascular pressure monitoring, to be produced in compliance with all applicable regulatory and performance standards for commercial medical devices. The work encompasses end-to-end production processes including component sourcing, assembly, testing, packaging, and documentation to ensure consistent quality and regulatory compliance, with all activities aligned to the requirements of a Class II medical device under FDA and international standards. The contract is structured as a subcontract under the Department of Defense’s Medical Supply Chain initiative, with performance required at Travis Air Force Base, California, 94535-1825, and responses due by May 18, 2026. Production must adhere to strict quality control protocols including statistical process control, lot traceability, and validated cleaning and sterilization methods, ensuring the device meets military and clinical specifications for reliability and safety in operational environments. The NAICS code 339112 indicates classification under Medical Equipment and Supply Manufacturing, underscoring the requirement for certified manufacturing facilities and personnel trained in medical device production under ISO 13485 and 21 CFR Part 820. All delivered units must be fully documented with appropriate labeling, unit-level tracking, and compliance certificates, and must be capable of integration into existing military medical systems without requiring modification. Deliverables include finished products, associated technical documentation, and quality records to support ongoing regulatory audits and field performance monitoring.