Access stays under the clinic's control
Patient files and scan data are stored encrypted. Only users your clinic authorizes can open them; data is never sold to third parties.
Data security, regulation and clinical responsibility
HomeTrust & Regulation
Who can access patient data, where liability sits under the regulations, and which steps Clonify leaves to your approval.
System suggestedClinician approved
The clinician-approved automation philosophy
Automation in Clonify runs on deterministic geometry algorithms: the same input always gives the same output, so results are predictable and verifiable. The software does not diagnose or decide treatment. It measures, proposes a design and waits for the clinician's approval.
Only users you authorize can open scans and designs. The production file (STL) is not released without clinician approval.
Data-protection compliant processing
Personal data is processed in line with applicable data-protection law.
Compliant with custom-made device regulation
Under custom-made medical device regulation, manufacturer responsibility stays with the clinic; Clonify strengthens the clinic's regulatory file by recording every design step.
The decision always stays with the clinician
The clinician decides on trimlines, regional shaping and delivery. The software does not pass these steps without approval.
Every step is recorded
Every device's design history, measurements and approvals are archived automatically. When a medicolegal question arrives, your file is ready.
Quality roadmap
Work to align our quality management system with the ISO 13485 framework is ongoing; we will keep the status current on this page.
The lifecycle of your data
| Stage | Practice |
|---|---|
| Collection | Scan data is collected at the clinic with the patient's/guardian's informed consent. |
| Storage | Stored encrypted; access is role-based and logged. |
| Processing | Measurement and design run inside the clinic's account; data is not used for module training without anonymization. |
| Sharing | Report sharing is controlled by the clinic; data is never sold to third parties. |
| Deletion | Patient data is permanently deleted at the clinic's request; deletion is logged. |
If a device doesn't fit, who is liable?
Under the regulations, manufacturer responsibility for a custom-made device sits with the clinic. That was true with plaster too, and Clonify doesn't change it. What changes is that when a device doesn't fit, you don't have to remember what was done at which step: it's in the record.
Let's answer your security and regulatory questions directly
If you want technical detail on access control, encryption or our regulatory position, talk to our team.