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Regulatory Compliance & Quality Assurance Support

Open
Federal

Contract Overview

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

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A subcontract has been issued under the Department of Veterans Affairs 261-NETWORK Contract Office 21 to provide comprehensive third-party validation of medical implant compliance with FDA regulations, ISO quality standards, and VA-specific quality requirements. The scope includes rigorous auditing procedures and full documentation support to ensure all implants meet regulatory benchmarks for safety, performance, and traceability. The work is classified under NAICS code 541690, indicating it involves other scientific and technical consulting services, and is intended to reinforce quality assurance throughout the implant lifecycle. The contract is set to be active beginning July 12, 2026, with performance expectations tied to federal compliance frameworks without specific geographic constraints identified. This engagement is critical to safeguarding veteran healthcare outcomes by ensuring all biomedical devices adhere to the highest standards of regulatory and operational integrity.

General Info

Third-party validation of medical implants for FDA, ISO, and VA compliance starting July 12, 2026.

NAICS

541690 - Other Scientific and Technical Consulting Services

Place of Performance

CA

Set-Aside

NONE

Documents

This scope was carved out of 36C261AP264445.

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

View the prime solicitation

6515--PROS-06162026-1836245-NC-ERA HEALTH (VA-26-00076611)

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 261-NETWORK Contract Office 21 (36C261)
ContactsNo contacts available
OfficeN/A
Office AddressN/A
ContactsNo contact information available

Full Description

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Third-party validation of implant compliance with FDA, ISO, and VA quality standards, including audit and documentation support.

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