Regulatory disclaimer and scope of service

The service does not perform medical diagnoses, does not prescribe treatments, does not replace the assessment of a healthcare professional and does not autonomously determine the clinical suitability of an insole for a specific patient. Responsibility for the indication, prescription, clinical design, final validation and use of the product always lies with the professional or organization requesting the service.

For print-only orders, the customer declares that the digital file submitted has been designed, reviewed and approved by qualified personnel, and that they hold the authority, consent and documentation needed to commission its manufacture. In these cases, our involvement is limited to the technical production of the part according to the file and specifications provided by the customer, without modifying its clinical purpose or assuming the role of prescriber or legal manufacturer of the medical device, unless expressly agreed in writing.

Where the service includes scanning, digitization or computer-aided design tools, these are offered as technical support for the professional workflow. Final validation of the design and its suitability for the patient must always be carried out by the responsible professional before manufacture or delivery.

Custom insoles may be subject to the applicable regulations on custom-made medical devices, depending on the country, intended purpose, distribution channel and role assumed by each party. Each customer is therefore responsible for verifying their own regulatory, professional and documentation obligations in the territory where they operate.

Our company maintains internal procedures for traceability, file control, production control and quality management aimed at ensuring a safe, reproducible and documented service. However, unless expressly stated otherwise, use of the platform or the manufacturing service does not imply that the company acts as a certifying body, healthcare prescriber or party clinically responsible for the patient's treatment.