This article explains the regulatory status of CustoMED and what it means for how you use it. It is for surgeons, clinical teams and organization admins who use CustoMED in clinical workflows.

CustoMED offers two solution environments. Both support patient-specific planning and design, but they differ in regulatory status and in where they are available:

The CustoMED Viewer is regulated medical device software. It is CE marked for use in Europe and FDA cleared in the United States.

The Viewer brings planning, design, review and print-ready output together in a single cloud interface. You work closely with the CustoMED team in a controlled, review-driven workflow, which also makes it suitable for complex, non-standard and highly customized indications. Every step is reviewed before the case is finalized, which supports accuracy, traceability and clinical review.

The CustoMED Platform adds capabilities for planning and designing a case directly in the cloud interface, from scan to patient-specific design. You review each step, adjust it with the tools of that step, and approve the result.

At this time, these capabilities are not CE marked and are not FDA cleared. Their availability is limited to specific regions, selected customers and controlled use cases, such as pilot programs, evaluations or non-standard workflows agreed with CustoMED.

Every result must be reviewed by qualified professionals, and use of these capabilities is subject to local regulatory and contractual limitations.

Which environment you use depends on regulatory requirements, your location and the nature of the case. The CustoMED Viewer is intended for regulated clinical workflows that need structured review. The additional capabilities of the CustoMED Platform are intended for limited, controlled use where they are permitted.

Available features may vary by region and customer account. If you are not sure which workflows are enabled for your organization, see When to Contact CustoMED Support.

CustoMED software supports design workflows but does not provide medical advice, diagnoses or treatment decisions. Everything the platform produces is a tool for review and must be evaluated and approved by qualified healthcare professionals before use.

Final responsibility for clinical decisions and device use always remains with the treating clinician, in accordance with local regulations and professional standards.