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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.

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The contract requires comprehensive regulatory and compliance support for surgical systems, ensuring full adherence to FDA standards through accurate documentation, proper labeling, and robust traceability systems. This includes assistance with import and export procedures to facilitate seamless global distribution while maintaining regulatory integrity at every stage of the supply chain. The work is structured as a subcontract under the Department of Veterans Affairs, specifically managed by the 249-NETWORK Contract Office 9, with performance centered in Louisville, Kentucky, and tied to the NAICS code 541611 for management consulting services. All deliverables must align with federal medical device regulations to support the VA’s operational and compliance needs.

General Info

Regulatory compliance support for surgical systems under VA contract in Louisville, Kentucky, ensuring FDA adherence and global distribution.

Agency

Department Of Veterans Affairs → 249-NETWORK Contract Office 9 (36C249)View Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Louisville, KY, 40206, USA

Set-Aside

NONE

Documents

This scope was carved out of 36C24926N0592.

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

View the prime solicitation

Louisville VAMC Da Vinci Robot Systems

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Timeline

PostedJun 22

subcontract

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 249-NETWORK Contract Office 9 (36C249)

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Veterans Affairs → 249-NETWORK Contract Office 9 (36C249)

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Office AddressN/A

ContactsNo contact information available

Full Description

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Provide FDA-compliant documentation, labeling, import/export support, and regulatory traceability for the delivered surgical systems.

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