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Regulatory Compliance & Quality Assurance 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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This contract involves providing regulatory consulting and quality assurance support focused on key compliance areas such as FDA submissions, ISO 13485 audits, lot traceability, and Veterans Affairs (VA) compliance reporting. The services under this subcontract are designed to assist in navigating complex regulatory requirements, ensuring adherence to quality standards, and maintaining thorough documentation and traceability throughout production and reporting processes. Issued by the Department of Veterans Affairs under the 250-NETWORK Contract Office 10 (36C250), this engagement falls under the NAICS code 541611, which relates to Administrative Management and General Management Consulting Services. Details regarding the specific location of performance and points of contact are not provided, but the work centers around supporting regulatory and quality assurance activities critical to medical device or healthcare-related projects requiring careful regulatory oversight and alignment with federal standards and VA regulations.

General Info

Regulatory consulting and quality assurance for FDA, ISO 13485, and VA compliance under VA contract.

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 36C25026AP3923.

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

View the prime solicitation

6515--SUPPLY-HEART VALVE- CLEVELAND

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Timeline

PostedJun 12

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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)

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Office AddressN/A

ContactsNo contact information available

Full Description

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Regulatory consulting and QA support for FDA submissions, ISO 13485 audits, lot traceability, and VA compliance reporting.

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