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ECG Bench experiments

Active

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The Food and Drug Administration is seeking to procure specialized test equipment to conduct ECG bench experiments. These hardware resources are essential for generating the scientific evidence required to develop a Regulatory Science Tool, which will ensure the delivery of a rigorous and high-quality framework for evaluating medical technology. The primary objective of this procurement is to enhance patient safety and streamline the regulatory process for innovative AI/ML Software as a Medical Device based on ECG data. This effort is being managed by the FDA, with coordination handled through the CDRH Acquisition Liaison.

General Info

FDA seeks specialized ECG test equipment to develop a medical technology regulatory tool.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

AI Contract Breakdown

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Timeline

PostedJan 1

forecast

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cdrh Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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Procuring the requested test equipment is a critical step in generating the scientific evidence necessary to support development of a Regulatory Science Tool (RST). These hardware resources will enable OSEL to deliver a rigorous, high-quality RST that promotes patient safety while facilitating timely access to innovative ECG-based AI/ML Software as a Medical Device (SaMD).

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