VA is seeking sources capable of full lifecycle sustainment, operational support, bug/fix development, and regulatory compliance for the existing VHA VBECS, an FDA-regulated Class II medical device software product. The contractor must plan, manage, develop fixes, test, deploy, maintain, document, and continuously monitor VBECS throughout the DevOps lifecycle. The contractor must maintain system documentation with accuracy, traceability, and compliance with FDA Quality System Regulations (21 CFR 820), ISO 13485:2016, and VA cybersecurity and privacy requirements. The contractor must also support maintenance of VBECS’s existing Authority to Operate, including documentation preparation, validation, and submission within the SNOW Continuous Authorization and Monitoring environment, plus audits, assessments, and security reviews.

The VA is seeking sources to provide full lifecycle sustainment, operational support, bug/fix development, and regulatory compliance services for the existing VHA VBECS, an FDA-regulated Class II medical device software product. The contractor must plan, manage, develop fixes, test, deploy, maintain, document, and continuously monitor VBECS throughout the DevOps lifecycle. The contractor must maintain system documentation with accuracy, traceability, and compliance with FDA Quality System Regulations (21 CFR 820), ISO 13485:2016, and VA cybersecurity and privacy requirements. The contractor must also support maintenance of VBECS’s existing Authority to Operate, including documentation preparation, validation, and submission within the SNOW Continuous Authorization and Monitoring environment, plus ongoing audit, assessment, and security review support.