Description
The National Institutes of Health is seeking a sole‑source contractor to provide annual preventive maintenance, calibration, software updates, inspections, diagnostic testing, troubleshooting, repair, and parts replacement for seven Miltenyi CliniMACS Prodigy automated cell‑processing instruments used in FDA‑regulated cGMP manufacturing. The contractor must be the original equipment manufacturer (OEM) or an authorized service provider and must deliver maintenance reports for quality‑assurance review. This effort ensures continuous operation of critical cell‑therapy production equipment for clinical trials.
• Scope includes preventive maintenance, calibration, software patches, and full repair support for 7 instruments (Serial Numbers 0327, 611, 1223, 1326, 1415, 1855, 917006).
• Services must comply with FDA 21 CFR 211.63/211.67 and maintain validated operating conditions within cGMP facilities.
• Contractor must submit capability statements by the deadline; no competitive quotations are being solicited.
Attached files
The solicitation documents live at the source — open the bid source above to download them.