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Regulatory and Quality 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 delivers ongoing regulatory and quality compliance support for implanted medical devices, focusing on FDA reporting, post-market surveillance, quality audits, and the maintenance of accurate regulatory documentation. This work ensures adherence to evolving federal standards and facilitates continuous compliance throughout the device lifecycle. The efforts are critical to maintaining market authorization, mitigating risk, and supporting patient safety through rigorous monitoring and documentation practices. This subcontract is managed under the Department of Veterans Affairs through the 250-NETWORK Contract Office 10 (36C250) and falls under NAICS code 541611, indicating a focus on management consulting services. The contract was posted on April 30, 2026, and does not specify a set-aside status or location of performance. The scope requires specialized expertise in medical device regulations and quality systems to support federal compliance obligations without direct oversight from the original solicitation source.

General Info

Regulatory and quality compliance support for implanted medical devices under VA contract 36C250, ensuring FDA adherence and patient safety.

Agency

Department Of Veterans Affairs → 250-NETWORK Contract Office 10 (36C250)View Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

OH

Set-Aside

NONE

Documents

This scope was carved out of 36C25026AP3455.

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

View the prime solicitation

6515--SUPPLIES-IMPLANTABLE PULSE GENERATOR- DAYTON

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Timeline

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 250-NETWORK Contract Office 10 (36C250)
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Veterans Affairs → 250-NETWORK Contract Office 10 (36C250)
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Ongoing support for FDA reporting, post-market surveillance, quality audits, and regulatory documentation for implanted devices.

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