Combined Synopsis/Solicitation & Notice of Intent to Sole Source: Purchase of a Factory-Certified Refurbished HUMIMIC Starter Kit Control Unit

The U.S. Food and Drug Administration (FDA) is seeking to purchase a factory-certified refurbished HUMIMIC Starter Kit Control Unit from the original equipment manufacturer, TissUse GmbH. This system is required for multi-organ-on-a-chip microphysiological research, and the FDA has determined that only TissUse GmbH can provide the necessary proprietary software source codes, diagnostic calibration fixtures, and engineering data to execute the required factory recertification and maintenance. The scope of work includes the delivery of the refurbished control unit, mandatory recertification and technical service, and a replacement part loaded with proprietary system firmware. The selected vendor will be required to provide a comprehensive 1-year manufacturer warranty and comply with Section 508 accessibility standards. Key aspects of the job include: • Providing a factory-certified refurbished HUMIMIC Starter Kit Control Unit • Performing mandatory recertification and technical service • Delivering a replacement part loaded with proprietary system firmware • Providing a comprehensive 1-year manufacturer warranty • Complying with Section 508 accessibility standards