Medical Device Sterilization Services

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.