Understanding the CustoMED Solutions
CustoMED provides two primary solution environments that serve different purposes and operate under different regulatory frameworks:
CustoMED Viewer (Cloud Lab)
CustoMED Platform (AI Lab)
While both environments support patient-specific planning and design workflows, they differ in their level of automation, regulatory approval, and geographic availability.
CustoMED Viewer (Cloud Lab): Regulated Clinical Workflow
The CustoMED Viewer, also referred to as Cloud Lab, is a regulated medical device software. It is CE marked for use in Europe, and FDA clearance is currently in progress in the United States.
Cloud Lab is designed as an engineer-supported planning and design environment, enabling close collaboration between CustoMED engineers and surgeons. This approach allows complex, non-standard, and highly customized indications to be handled within a controlled, review-driven workflow.
Cloud Lab transforms traditionally complex processes into a guided, cloud-based experience that brings planning, design, review, and print-ready output into a single interface. Human oversight is embedded throughout the workflow to support accuracy, traceability, and clinical review.
How Cloud Lab Works
[ 1 ] Upload Scan
[ 2 ] Engineer Designs / Approves
[ 3 ] Surgeon Reviews
[ 4 ] Print-Ready Output
CustoMED Platform (AI Lab): Fully Automated Capabilities
The AI Lab includes CustoMED’s fully automated, AI-supported planning and design features. These capabilities are designed to dramatically accelerate digital workflows by enabling scan analysis, planning, and patient-specific design in minutes, without direct engineer intervention.
At this time, AI Lab features are not CE marked and are not FDA cleared. As a result, their availability is limited to specific regions, selected customers, and controlled use cases, such as pilot programs, evaluations, or non-standard workflows agreed upon with CustoMED.
AI Lab demonstrates how automation can streamline planning and production, while still allowing surgeons to review, adjust, and approve auto-generated outputs within the same cloud interface.
How AI Lab Works
[ 1 ] Upload Scan
[ 2 ] AI Generates
[ 3 ] Surgeon Adjusts
[ 4 ] Print-Ready Output
All AI-generated outputs must be reviewed by qualified professionals, and their use is subject to local regulatory and contractual limitations.
Choosing the Workflow
The choice between Cloud Lab and AI Lab depends on regulatory requirements, geographic location, and the nature of the case. Cloud Lab is intended for regulated clinical workflows where engineer support and structured review are required. AI Lab is intended for limited, controlled use where automation is appropriate and permitted.
Availability of specific features may vary by region and customer account. If you are unsure which workflows are enabled for your organization, we recommend contacting CustoMED support.
Important Regulatory Considerations
CustoMED software is intended to support design workflows but does not provide medical advice, diagnoses, or treatment decisions. All outputs generated by the platform are tools for review and must be evaluated and approved by qualified healthcare professionals prior to use.
Final responsibility for clinical decisions and device use always remains with the treating clinician, in accordance with local regulations and professional standards.