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Medical Device Regulatory Compliance & Quality Assurance

Active
Federal

Contract Overview

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

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This contract supports comprehensive regulatory compliance and quality assurance activities for medical devices, focusing on alignment with FDA and Department of Veterans Affairs requirements. It encompasses the development and maintenance of quality system documentation, preparation and submission of regulatory filings, implementation of post-market surveillance protocols, and ensuring ongoing audit readiness across all operational phases. The work is critical to maintaining device safety, efficacy, and regulatory adherence throughout the product lifecycle. The contract is structured as a subcontract under a Service-Disabled Veteran-Owned Small Business Set Aside, identifying the NAICS code 541611, which categorizes it under Management, Scientific, and Technical Consulting Services. It is issued by the Department of Veterans Affairs through the Sac Frederick office and was posted on July 27, 2026. The performance location and specific point of contact are not detailed, but the obligation to meet stringent federal regulatory standards applies uniformly across all deliverables. The set-aside classification ensures prioritization for eligible small businesses owned and controlled by service-disabled veterans.

General Info

Subcontract for FDA and VA compliance services under service-disabled veteran-owned small business set-aside.

Agency

Department Of Veterans Affairs → Sac Frederick (36C10X)View Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

MD

Set-Aside

SDVOSBC

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 → Sac Frederick (36C10X)
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Veterans Affairs → Sac Frederick (36C10X)
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Support for quality system documentation, regulatory submissions, post-market surveillance, and audit readiness per FDA and VA requirements.

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