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This Government Contract opportunity from Department Of Health And Human Services was posted on June 3, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Regression Testing & System Qualification for CDS Applications

Closed
Federal

Contract Overview

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This contract involves performing regression testing and system qualification on the Empower and NuGenesis clinical decision support (CDS) applications following their migration. The goal is to verify that these applications maintain full functionality, ensure data integrity, and comply with FDA validation standards. The work is critical to confirm the systems continue to meet all regulatory requirements post-migration. The contract is a subcontract issued by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services. It is classified under NAICS code 541380 and requires completion of testing in Detroit, Michigan, ZIP code 48207. The contract was posted on June 3, 2026, with a response deadline of June 18, 2026. This effort supports the FDA’s continued assurance of reliable and validated CDS software tools important to regulatory compliance and public health.

General Info

Perform regression testing and qualification of Empower and NuGenesis CDS applications post-migration per FDA standards.

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant SvcsView Agency

NAICS

541380 - Testing Laboratories and ServicesView NAICS

Place of Performance

Detroit, MI, 48207, USA

Set-Aside

NONE

Documents

This scope was carved out of FDA-75F40126Q00166.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → FDA Office Of Acq Grant Svcs
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Perform regression testing and system qualification of Empower and NuGenesis applications post-migration to ensure functionality, data integrity, and compliance with FDA validation standards.

More opportunities from Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

Same awarding agency

NAICS: 541714
New
Federal
Human Hindbrain Organoid Functional Assay Services.
Solicitation # RFQ_CDR-2026-135968
The U.S. Food and Drug Administration, through the Center for Drug Evaluation and Research, intends to award a sole-source, firm-fixed-price purchase order to OrganoTherapeutics SARL for human iPSC-derived hindbrain organoid functional assay services. This acquisition, conducted under FAR Part 12 as a commercial service, aims to support in vitro research on drug-induced effects on respiratory-relevant neural circuits. The scope of work includes the provision of human hindbrain organoids and associated culture materials, with twelve scheduled deliveries to the FDA White Oak Campus in Silver Spring, Maryland. The first delivery will consist of 96 organoids, followed by eleven subsequent deliveries of 48 organoids each. The contractor will perform functional characterization at its own laboratory using three-dimensional multi-electrode array technology to assess electrophysiological responses to FDA-identified drug and reversal-agent combinations. Key deliverables include the raw and analyzed data, analysis files, and comprehensive study reports. The anticipated period of performance is 18 months from the date of award. Award will be based on best value, with technical capability and past performance weighted more heavily than price. All invoicing must be processed electronically through the U.S. Department of Treasury's Invoice Processing Platform.
Research and Development in Biotechnology (except Nanobiotechnology)

POSTED

about 19 hours ago

DEADLINE

in 5 days
View Details

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