This article explains how a case moves through CustoMED, how your organization's supervision type affects reviews and approvals, and the regulatory position of the platform. It is for surgeons, clinical teams and organization admins who want to understand how a case is handled from start to finish.
The CustoMED Platform is a cloud-based medical software solution designed to support the creation, review, and delivery of patient-specific instruments (PSI) and anatomical models for orthopedic procedures.
Every case moves through a series of steps that depend on the procedure, for example Segmentation, Landmarks, Surgery Planning and PSI Design. In each step you see the result on screen, adjust it with the tools of that step, and confirm it or reject it with a note. When every step is confirmed, you approve the case.
CustoMED's goal is to provide the best possible clinical outcome and user experience for every case, procedure and region.
Platform building blocks
The CustoMED platform is composed of several core capabilities:
Case Management & Indication Apps: select the procedure type and manage cases
Secure DICOM Upload & Client-Side Anonymization
Segmentation Viewer: review and approve anatomy
Viewer & Editor: visualization, measurement, annotation, and planning (based on permissions)
PSI Design: review the patient-specific guide, change its type and adjust its parameters
Role-Based Access Control (RBAC): separation of clinical and back-office responsibilities
Audit Trails & Approvals: full traceability
Supervision types
Every organization has one supervision type. It applies to all users and all cases in that organization, and it is set by CustoMED. If you belong to several organizations, each one can have a different supervision type. When your organization is Supervised or Viewer, a Supervised or Viewer label is shown at the bottom of the screen.
Supervision type | How approval works |
Unsupervised | Your approval completes the case. |
Supervised | The case needs your approval and a back-office approval. If you approve first, the case is locked and sent for back-office review, and its status shows Awaiting Final Review. If the back office approves first, the case waits for your approval. |
Viewer | You review the result of each planning step in a single 3D Viewer view. When you confirm a step that is not ready yet, the case is sent for back-office review instead of moving on. As with Supervised, the case needs both your approval and a back-office approval. |
The back office is your organization's Organization Back Office users or the CustoMED back-office team. For what happens during review, see Approving a Case. For every stage a case moves through, see The Case Lifecycle Explained.
Clinical responsibility
Every segmentation, plan and PSI must be reviewed and approved by an authorized user before export.
CustoMED makes no diagnostic claims and does not replace clinical judgment.
Final clinical decisions are always made by the treating clinician.
For the regulatory status of CustoMED, see Regulatory Status and Use of the CustoMED Platform.
Service levels and turnaround time
Standard target: within 24 hours for segmentation, review, or planning
Urgent or critical cases: if more immediate support is required, please contact the CustoMED team directly so priority handling can be arranged.
Turnaround time may vary depending on:
Indication complexity
Data quality
Regulatory constraints
Regions of operation
CustoMED supports users across multiple regions, with workflows adapted to local requirements:
United States
European Union
Other regions (subject to local regulatory alignment)
Available features and procedures may vary by region.
Indication support
Each procedure is offered as an Indication App
The procedures available to you depend on your organization's license and region
If the procedure you need is not listed, contact CustoMED. We can often still help.