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Quality Assurance and Regulatory Compliance Support

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Federal

Contract Overview

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

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The contract involves providing third-party quality assurance and regulatory compliance support specifically for a Transcatheter Aortic Valve Replacement (TAVR) device. The scope includes ensuring the device meets relevant FDA, Veterans Affairs, and ISO standards through activities such as documentation review, audit assistance, and lot testing. This effort supports the Department of Veterans Affairs, managed by its Network Contract Office 23. Classified as a subcontract under NAICS code 541380, the engagement focuses on adhering to stringent industry and regulatory requirements to guarantee the safety and efficacy of the device. While specific logistical details like location and points of contact are not provided, the contract demonstrates the VA's commitment to maintaining high-quality standards in medical device procurement and validation. The contract was posted on October 27, 2025, emphasizing the ongoing need for rigorous compliance checks in healthcare technologies serving veterans.

General Info

Provide quality assurance and regulatory compliance support for TAVR device meeting FDA and VA standards.

Agency

Department Of Veterans Affairs → Network Contract Office 23 (36C263)

NAICS

541380 - Testing Laboratories and Services

Place of Performance

MN

Set-Aside

NONE

Documents

This scope was carved out of 36C26326Q0080.

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

View the prime solicitation

6515--PROS V23 618 UNU BILL & REPLACE 6182973294 (MI) TAVR (NEED ON OR BEFORE 10/28/2025) (VA-26-00019389)

AI Contract Breakdown

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Timeline

PostedOct 27

subcontract

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → Network Contract Office 23 (36C263)

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Veterans Affairs → Network Contract Office 23 (36C263)

Office AddressN/A

ContactsNo contact information available

Full Description

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Third-party validation of TAVR device compliance with FDA, VA, and ISO standards, including documentation review, audit support, or lot testing.

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