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ISO 13485-Compliant Service Process Development and Documentation

Active

Federal

Response Deadline08/03/2026, 03:00:00 PM UTC

Contract Overview

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

AI Contract Overview

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The contract involves the development and validation of ISO 13485:2016-compliant procedures for the cleaning, disinfection, inspection, and quality control processes specific to Alaris pumps, ensuring alignment with international medical device standards. The work requires creating detailed, auditable documentation that meets regulatory expectations, with support provided during internal and external audits to demonstrate compliance and operational readiness. All procedures must be validated through rigorous testing and verification to guarantee consistency, safety, and effectiveness in maintaining the integrity of the Alaris pump systems. The project is classified as a subcontract under NAICS code 541611 and is managed by the Department of Veterans Affairs through its 249-NETWORK Contract Office 9. Performance is designated to take place in Louisville, Kentucky, with a posted date of July 23, 2026, and a mandatory response deadline of August 3, 2026. Subcontractors are expected to deliver fully documented, compliant processes that can be seamlessly integrated into existing quality systems, with no set-aside provisions applying to this opportunity.

General Info

Develop ISO 13485:2016-compliant cleaning and quality procedures for Alaris pumps in Louisville, Kentucky by August 3, 2026.

Agency

Department Of Veterans Affairs → 249-NETWORK Contract Office 9 (36C249)View Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Louisville, TN, 40206

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedJul 23

subcontract

Response DeadlineAug 3

Submission deadline

Response Deadline

08/03/2026, 03:00:00 PM UTCin 8 days

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 249-NETWORK Contract Office 9 (36C249)

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Veterans Affairs → 249-NETWORK Contract Office 9 (36C249)

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Office AddressN/A

ContactsNo contact information available

Full Description

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Development and validation of ISO 13485:2016-compliant procedures for cleaning, disinfection, inspection, and quality control of Alaris pumps, including audit support.

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