CI/CD Pipeline Design for Medical Devices

To design a CI/CD pipeline for medical device software that meets IEC 62304 compliance, include mandatory stages for linting, SAST, unit/integration testing, coverage analysis, package signing, and artifact archival with full traceability and audit trails.

A regulated CI/CD pipeline for a Class C medical device requires stages for lint/SAST, building, unit and integration testing, coverage verification, package signing, and artifact archival to ensure build provenance and artifact integrity.

You ensure auditability and traceability in medical device CI/CD pipelines by capturing build provenance, enforcing access control, and linking archived artifacts directly to requirements and tests throughout the pipeline stages.

Standard CI/CD pipeline tools can be used for regulated medical device codebases if they are configured to enforce environment parity, secure credential management, comprehensive logging, and strict artifact integrity checks.

The best way to implement artifact management and build provenance for medical device software is to configure pipelines with strict access control, package signing, and comprehensive logging that links artifacts to their exact build environments.

Your medical device software pipeline needs SAST and package signing integrated to satisfy security best practices, enforce artifact integrity, and provide the audit trails required for stringent regulatory compliance.