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Regulatory and Quality Compliance Support

Active

Federal

Response Deadline08/04/2026, 06:00:00 PM UTC

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 contract seeks specialized regulatory and quality compliance support to ensure an imaging table complies with FDA, CE, and ISO 13485 standards, focusing on the preparation of a comprehensive technical file and achieving audit readiness. The scope includes detailed documentation development, process alignment with international medical device regulations, and ongoing consulting to maintain ongoing compliance throughout the product lifecycle. All deliverables must meet the rigorous requirements of global regulatory bodies to facilitate market access and certification. The work is to be performed in Cheyenne, Wyoming, under a subcontract arrangement by a vendor responding to the Department of Veterans Affairs through its Network Contract Office 19. Proposals are due by August 4, 2026, and the effort falls under NAICS code 541611, which classifies it as management, scientific, and technical consulting services. While no set-aside designation is specified, the solicitation is open to qualified subcontractors capable of delivering regulatory expertise in the medical device sector, with a clear emphasis on technical documentation accuracy and operational readiness for third-party audits.

General Info

Regulatory compliance support for imaging table to meet FDA, CE, ISO 13485 with technical file and audit readiness in Cheyenne, Wyoming.

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

Cheyenne, WY, 82001, USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedJul 24

subcontract

Response DeadlineAug 4

Submission deadline

Response Deadline

08/04/2026, 06:00:00 PM UTCin 9 days

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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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Provide documentation and consulting support to ensure the imaging table meets FDA, CE, and ISO 13485 requirements, including technical file preparation and audit readiness.

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