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.
The system suggests, the clinician approves. The liability framework is clear from the start.
HomeTrust & Regulation
In medical software, trust is built on data security, regulatory compliance and writing down explicitly who holds decision authority. This page spells out all three.
System suggestedClinician approved
The clinician-approved automation philosophy
Automation in Clonify runs on deterministic geometry algorithms: the same input always produces the same output — predictable and verifiable behaviour. The system never diagnoses or decides treatment at any step; it measures, suggests and waits for the clinician's approval. This is not a limitation but a deliberate design choice: in medical software, predictability is exactly what regulators and physicians want.
The production file needs clinician approval. Only authorized users can open scans and designs; no STL leaves without that sign-off.
Data-protection compliant processing
Data is stored encrypted; access is limited to users authorized by your clinic. Processing follows 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
Clinical judgements such as trimlines, regional shaping and the delivery decision cannot be delegated to software; critical steps do not advance without clinician approval.
Traceability is architecture, not a by-product
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. |
Liability is asked often; our answer is clear
The answer to “who is liable?” is set by regulation: for custom-made devices, manufacturer responsibility already sits with the clinic — as it did in the plaster era. Clonify does not change that responsibility; it strengthens the clinic's hand by recording every step. For an ill-fitting device, the answer to “what was done at which step?” now lives in the system, not in memory.
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.