This is a notice of intent for a sole-source award to Tissuse GmbH for a factory-certified refurbished Humimic starter kit control unit. The FDA requires this specific unit due to Tissuse GmbH being the sole developer and patent holder with proprietary software and data. The procurement includes the control unit, mandatory OEM recertification and technical services, an SSD replacement part, and coordinated onsite technical deployment. Delivery is required within 60 days of order. Quotes are due by email by August 1, 2026, 1:00 PM Central Time.
Delivery shall be completed within 60 days of contract award at the specified FDA address.
Net 30 days after government acceptance of a proper invoice, which shall only be submitted after products have been delivered and accepted at the destination point. Advance payments will not be made.
Systems shall be warranted for a minimum of one (1) year from FDA acceptance of the system. Warranty services include troubleshooting, immediate access to replacement parts, and system firmware improvements and updates. Phone and email technical support shall be included for a minimum of one (1) year.
The government intends to award a firm-fixed-price commercial contract to the original equipment manufacturer (OEM), Tissuse GmbH, whose quote, conforming to the solicitation, will be most advantageous to the government, price and other factors considered. Quotes/capability statements will be evaluated strictly on a pass/fail basis on their ability to meet the explicit OEM brand name requirements.
To be deemed technically acceptable, the respondent must provide conclusive, documented technical evidence demonstrating that they are the OEM Tissuse GmbH or a factory-certified entity possessing the proprietary factory diagnostic fixtures, source code/firmware, and legal authorization necessary to perform technical calibration, maintenance, and mandatory recertification on the specified hardware.
Submissions from any entity unable to verify direct factory chain-of-custody from the OEM manufacturing facility will be deemed technically unacceptable and will not be evaluated. Documents submitted with macros will be considered nonresponsive.