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FDA Medical Device Quality Management & Regulatory Compliance

Open

Federal

Response Deadline11/30/2026, 01:00:00 PM EST

Contract Overview

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

General Info

Agency

Department Of Veterans Affairs → Technology Acquisition Center Nj (36C10B)

NAICS

541611 - Administrative Management and General Management Consulting Services

Place of Performance

NJ

Set-Aside

NONE

Documents

This scope was carved out of 36C10B27Q0056.

The full solicitation package (3 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

DA01--Veterans Health Information Systems and Technology (VISTA) Blood Establishment Computer Software (VBECS) Operations and Maintenance Support II

AI Contract Breakdown

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Timeline

PostedNov 12

subcontract

Response DeadlineNov 30

Submission deadline

Response Deadline

11/30/2026, 01:00:00 PM ESTin 18 days

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → Technology Acquisition Center Nj (36C10B)

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Veterans Affairs → Technology Acquisition Center Nj (36C10B)

Office AddressN/A

ContactsNo contact information available

Full Description

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Performs regulatory oversight and quality assurance for prime contractors on VA medical device software projects. Maintains the Quality Management System (QMS) per ISO 13485:2016 and 21 CFR Part 820, prepares FDA 510(k) applications, and manages Medical Device Reporting (MDR) and CAPA. Conducts hazard analysis and requirements traceability for regulatory audits. Delivers audit-ready QMS artifacts and compliance reports.

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