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Regulatory Compliance and FDA Submission 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 is for regulatory compliance and FDA submission support services focused on medical devices, requiring the preparation and ongoing maintenance of critical documentation including FDA 510(k) premarket notifications, Quality System Regulation (QSR) records, and Design History Files (DHF). The work involves comprehensive quality system support to ensure adherence to applicable regulatory standards throughout the product development and manufacturing lifecycle. The subcontract is aligned with NAICS code 541611, reflecting its classification under Administrative Management and General Management Consulting Services, and is issued under the Department of Veterans Affairs through the Nac Federal Supply Schedule. Performance of the tasks is not tied to a specific geographic location, allowing flexibility in execution while maintaining strict compliance with U.S. food and drug regulations.

General Info

Regulatory compliance and FDA submission support for medical devices with quality system documentation.

Agency

Department Of Veterans Affairs → Nac Federal Supply Schedule (36F797)View Agency

NAICS

541611 - Administrative Management and General Management Consulting Services View NAICS

Place of Performance

IL

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

subcontract

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → Nac Federal Supply Schedule (36F797)
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Veterans Affairs → Nac Federal Supply Schedule (36F797)
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Preparation and maintenance of FDA 510(k), QSR documentation, design history files (DHF), and quality system support for medical devices.

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