Compliance

Medical and MDR information

Podia3D is presented as a v0 prototype and is not currently certified as medical device software. It does not replace assessment, diagnosis, indication, fitting or follow-up by a qualified healthcare professional.

STL, 3MF and generated documents are working tools. MDR documentation is issued as a draft and must be reviewed, completed, signed and retained by the manufacturer responsible for the custom-made insole.

Any use with real patients requires clinical control, manufacturing validation, traceability, risk management and compliance with the regulations applicable in the relevant territory.

At this stage the landing page does not collect medical data or identifiable patient data. Do not send scans, clinical images, prescriptions or manufacturing files linked to patients through the contact form.

In case of discrepancy between translations, the Spanish version prevails.