This article explains what happens after you approve a case in CustoMED: the files you get, production options and timelines, the Logistics tracking steps, validation, sterilization and surgical readiness. It is for surgeons, planning staff and the lab or printing staff who produce the guides.
Important: All PSIs and anatomical models are provided non-sterile. Plan production, validation, sterilization and final use carefully around the scheduled surgery.
What happens after approval
Each approved output pack with a guide gets the status Ready for Production. A Plan Only case is Completed straight away.
The files for each pack are available in the Files tab of the case panel.
The plan and its parameters are locked.
Any further change requires reopening the case. The Organization Back Office or the CustoMED back-office team can reopen it.
All files reflect the final approved configuration.
Case status during production
Status | Meaning |
Ready for Production | The case is approved and at least one pack with a guide is waiting to be produced. |
In Production | Production has started: the print files were downloaded on the Logistics page, or the guide was marked as printed. |
Completed | Every pack has shipped, or the case has nothing to produce. |
Expected timelines
CustoMED aims to support cases as efficiently as possible while maintaining quality and safety.
Review and processing
We do our best to review and respond within 24 hours.
In some cases, processing may take up to 72 hours, depending on case complexity, surgeon availability and when in the week you submit (for example, weekends or holidays).
Production and delivery
Production time depends on the manufacturing option:
Centralized or third-party facilities may need an additional 1 to 2 days.
Point-of-care or in-house printing can often be completed the same day.
Important: To allow time for review, production, delivery and sterilization, submit cases so that the final PSI is available at least 72 hours before surgery whenever possible. For urgent cases, contact CustoMED support as early as possible.
What you receive
Each output pack can include, depending on the procedure and configuration:
PSI STL files: ready-to-print files of the guide geometry.
Anatomical models (STL): bone models for checking fit, when applicable.
Plan Report (PDF): a summary of the approved plan, key parameters and visual references. It supports traceability and review but is not an instruction for use.
Delivery Note (PDF), and after the Logistics steps, the DHR and labels.
All downloads are logged for audit purposes. See Downloading Files & Plan Reports for where to find each file.
Production options
Hospital in-house or point-of-care printing
Print PSIs and models with approved in-house equipment.
Same-day production is possible in many cases.
Follow your internal quality and validation procedures.
CustoMED-managed production
CustoMED coordinates production according to predefined specifications.
Finished parts are delivered to the hospital or designated facility.
Devices are delivered non-sterile.
Third-party manufacturing
Export the files to an external manufacturing partner.
Make sure the partner follows the right material, quality and handling requirements.
Track production on the Logistics page
The Logistics page records printing, validation and shipping for each approved pack with a guide. Open the case and select Logistics in the side navigation. It is available to the Organization Admin, Organization Back Office and Technician roles.
Each step unlocks when the one before it is done:
Download Files to Print: click Download files to get the STL files for this pack.
Mark as Printed: enter the Printing Material, Material LOT and Printer Serial Number, then click Confirmed as Printed.
Print Validation: for each printed part, confirm the fit, then enter the measured values the page asks for and click Confirm and Proceed, then Confirm and Finish on the last part. Values must be within the accepted range shown on the page. Parts without measurement data use Mark as Validated.
Logistics Files: click Download Logistics Files to create and download the DHR together with the Plan Report, Delivery Note and labels. Labels need a printing facility linked to your organization (see Medical Centers & Printing Facilities).
Shipping: optionally enter a Tracking Number, then click Mark as Shipped. This locks the pack's progress and data. You can use Cancel shipping if you need to undo it.
You can reopen a finished step until the pack is shipped.
Validation of printed PSIs
Before sterilization and surgical use, you must validate the printed PSI:
Confirm the printed geometry matches the approved digital model.
Check anatomical fit on a printed bone model, if available.
Inspect for print defects, deformation or surface issues.
Validation is the responsibility of the user or institution that performs the print. For printing labs, see Post-Processing, Inspection & Packaging Guidelines.
Sterilization and surgical use
CustoMED does not perform sterilization and does not deliver sterile devices. All PSIs and anatomical models are delivered non-sterile.
Sterilization must be performed by the hospital or designated production facility, according to CustoMED and hospital protocols.
CustoMED does not control sterilization methods or timelines. Sterilization time varies by institution and must be included in surgical planning.
The surgeon must confirm sterilization before use.
Important: The final decision to use the PSI is made intraoperatively by the surgeon. PSIs are optional tools that support, but do not replace, clinical judgment.