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Medical Device Regulatory Compliance Support

Active
Federal

Contract Overview

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

General Info

Agency

Department Of Veterans Affairs → Network Contract Office 19 (36C259)View Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Salt Lake City, UT, 84148, USA

Set-Aside

NONE

Documents

This scope was carved out of 36C25926Q0858.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

36C25926Q0858| Sources Sought on Brain Stimulator for Salt Lake City VA Medical Center

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Timeline

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → Network Contract Office 19 (36C259)
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Veterans Affairs → Network Contract Office 19 (36C259)
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Performs quality assurance auditing and regulatory documentation for prime contractors on Department of Veterans Affairs medical device procurements. Reviews manufacturer QA processes, verifies FDA compliance certifications, and prepares Buy American certifications and domestic content analysis per FAR Part 25. Utilizes regulatory compliance auditing frameworks. Delivers compliance reports and Quality Assurance certifications.

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OMB - PURCHASING

POSTED

about 20 hours ago

DEADLINE

in almost 5 years
View Details

More opportunities from Department Of Veterans Affairs → Network Contract Office 19 (36C259)

Same awarding agency

NAICS: 334510
New
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36C25926Q0858| Sources Sought on Brain Stimulator for Salt Lake City VA Medical Center
Solicitation # 36C25926Q0858
The Department of Veterans Affairs, through Network Contracting Office 19, is conducting a market survey to identify potential sources for a Transcranial Magnetic Stimulation (TMS) machine for the Salt Lake City VA Medical Center. This Sources Sought Notice, under NAICS code 334510, is intended for planning purposes to determine vendor capabilities and socioeconomic size classifications. Interested companies must submit their responses to Lynn Lim by 12:00 pm MT on September 14, 2026, providing company details, entity IDs, delivery timelines, and manufacturer information. The required equipment must be a biphasic waveform stimulator supporting repetitive (rTMS) and Intermittent Theta Burst Stimulation (iTBS) capabilities, featuring air-cooled figure-of-eight coils and a 3D navigation stim guide coil positioning system. The scope of work includes the procurement, delivery, installation, provider training, and ongoing maintenance of the machine at the George E. Whalen VA Medical Center in Salt Lake City, Utah. All equipment must comply with FDA regulations and medical device standards, incorporating safety features such as emergency stop buttons and software safeguards to prevent over-stimulation. Respondents must certify the country of origin for the end products using the Buy American Certificate (FAR 52.225-2) and demonstrate robust quality assurance processes. While the contractor will not have access to sensitive VA information, they are obligated to protect any PHI or PII in accordance with federal guidelines. This notice is for research only and does not constitute a solicitation or a commitment by the government to award a contract.
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