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Medical Device Sterilization Services

Active

Federal

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 outlines the provision of terminal sterilization services for Transcatheter Aortic Valve Replacement devices using ethylene oxide, gamma radiation, or electron beam methods, all performed in strict compliance with FDA regulations and ISO international standards to ensure safety and efficacy. The services must meet rigorous quality and validation requirements appropriate for Class III medical devices, with documentation and process controls aligned with current Good Manufacturing Practices and regulatory expectations for sterile product release. This is a subcontract under the Department of Veterans Affairs, managed by the Network Contract Office 23, and is classified under NAICS code 812910 for medical and dental laboratory services. The solicitation was posted on May 15, 2026, with no specified set-aside provisions or geographic limitations for performance. The contract requires adherence to regulatory compliance at every stage of sterilization, including validation, process monitoring, and batch release, with no indication of location restrictions for the sterilization facility, though performance must support the VA’s supply chain for critical cardiac devices.

General Info

Terminal sterilization of TAVR devices using ethylene oxide, gamma, or e-beam per FDA and ISO standards for VA supply chain.

Agency

Department Of Veterans Affairs → Network Contract Office 23 (36C263)

NAICS

812910 - Pet Care (except Veterinary) Services

Place of Performance

MN

Set-Aside

NONE

Documents

This scope was carved out of 36C26326Q0715.

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

View the prime solicitation

6515--PROS V23 618, UNU, BILL AND REPLACE, 6183152795 (MI) TAVR (DELIVER BY 05/19/2026) (VA-26-00068957)

AI Contract Breakdown

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Timeline

PostedMay 15

subcontract

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → Network Contract Office 23 (36C263)

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Veterans Affairs → Network Contract Office 23 (36C263)

Office AddressN/A

ContactsNo contact information available

Full Description

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Terminal sterilization of TAVR devices using ethylene oxide, gamma radiation, or e-beam methods in compliance with FDA and ISO standards.

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