FAQ

FAQ: Frequently asked questions - Orthofan Orthodontic Lab

FREQUENTLY QUESTIONS ABOUT QUALITY, DEVICES AND PROCEDURES

This section contains the most frequently questions (FAQs) addressed to Orthofan Orthodontic Laboratory by dentists, orthodontists and professionals in the field.
The aim is to provide clear and transparent information on operating procedures, custom-made medical devices, regulatory requirements, the Quality Management System, services offered and methods of collaboration.

FAQ: Frequently asked questions - Orthofan Orthodontic Lab

Orthofan operates as a manufacturer of custom-made medical devices, in compliance with Regulation (EU) 2017/745 (MDR) and the ISO 9001 and ISO 13485 certified management systems. This is why we believe it is essential to explain not only what we do, but also how and why we do it.

The answers on this page are intended to support Clinicians in their daily work, promote informed collaboration and contribute to patient safety, while respecting professional roles and responsibilities.

Quality System, Regulatory Compliance and Responsibility

Yes. Orthofan Orthodontic Laboratory operates with an ISO 9001 and ISO 13485 certified Quality Management System, applied to all stages of design, manufacture and control of custom-made orthodontic devices.
The certifications guarantee that every process is documented, controlled and constantly monitored over time.

Yes. Orthofan operates as a manufacturer of custom-made medical devices in full compliance with Regulation (EU) 2017/745 (MDR).
Each device is made exclusively on clinical prescription, accompanied by the required documentation and tracked in accordance with applicable regulatory requirements.

The Quality System allows technical know-how to be transformed into structured processes, reducing the risk of errors, improving product reliability and ensuring consistent quality over time.
In the field of Custom-Made Medical Devices, Quality does not only concern the final product, but the entire process leading to its creation.

This means that every stage – from receiving the clinical prescription to planning, production, final inspection and delivery – is defined, verified and recorded.
Even if the device is not mass-produced, the method used to manufacture it is always the same, validated and controlled.

Orthofan applies risk assessment and management procedures in line with MDR and ISO 13485 requirements.
This includes the analysis of materials, manufacturing processes, interactions with clinical prescriptions and final checks, with the aim of ensuring the safety, functionality and reliability of the device.

Yes. Every custom-made medical device manufactured by Orthofan is fully traceable, from the clinical prescription to the materials used, right through to the final inspection and delivery.
Traceability is a fundamental requirement for patient safety and clinician protection.

Yes. Before delivery, each device undergoes multiple final checks, performed according to documented procedures.
Only devices that comply with technical, functional and regulatory requirements are delivered to the clinician.

Clinical prescription, roles and responsibilities

Yes. A clinical prescription is required by law for the design and manufacture of any Custom-Made Medical Device.
It is the document that allows the laboratory to operate as a manufacturer in compliance with the MDR Regulation.

The clinical prescription must be completed exclusively by a qualified doctor who is duly registered with the professional association.
The laboratory cannot start production without a correctly completed prescription.

The clinical prescription must contain:

  • patient data
  • the type of medical device required
  • the clinical indications necessary for the planning
  • the Clinician’s full details, including registration with the professional association

Only a complete prescription allows for the correct project of the device.

A comprehensive prescription protects:

  • the patient, ensuring safety and clinical appropriateness
  • the clinician, who retains full therapeutic control
  • the laboratory, which can operate in compliance with regulations

The quality of the final device also depends on the clarity of the initial information.

Yes. Orthofan provides dedicated forms and technical support to facilitate the correct completion of clinical prescriptions, in accordance with the roles and responsibilities of each professional figure.

No. Any modification, addition or repair to a custom-made medical device must be expressly indicated by the clinician.
The laboratory always acts as the technical executor of the clinical instructions received.

Yes. Even in the event of modification, adaptation or repair, a new Clinical Prescription describing the required intervention is necessary.
This ensures regulatory continuity and traceability of the device.

Customised orthodontic devices and digital technologies

A custom-made orthodontic medical device is an appliance designed and made specifically for an individual patient, based on the clinician’s prescription.
Each device is unique and is the result of the integration of clinical indications, technical expertise and production process control.

Orthofan designs and manufactures a wide range of customised medical devices, including:

  • Removable Devices
  • fixed devices
  • functional devices
  • bite and gnathological devices
  • expanders and interceptive devices
  • traditional and thermoformed retainers
  • clear aligners
  • devices for treating sleep apnoea
  • professional sports mouthguards

All devices are produced in-house according to certified procedures.

Digital orthodontics enables extremely precise design of devices through:

  • digital scans
  • specialised CAD software
  • 3D virtual models

This approach allows us to optimise the design phase while maintaining artisanal control during the production phases.

No. Orthofan integrates advanced digital technologies with the manual know-how of specialised dental technicians.
Technology supports the process, but the final quality is the result of experience, human control and continuous verification of the device.

Yes. Clear aligners are fully customised medical devices.
Each set is designed based on the individual clinical case, manufactured in-house and subjected to specific checks before delivery to the clinician.

Orthofan uses only certified materials, selected based on criteria of safety, biocompatibility and stability over time.
Every material used is traceable and complies with applicable regulatory requirements.

Yes. Each device can be customised according to clinical indications, therapeutic needs and patient characteristics.
Customisation is an integral part of the concept of tailor-made medical devices.

The design of the orthodontic device, understood as a clinical and therapeutic definition, is the responsibility of the clinician and is formalised through the prescription.
The Orthofan laboratory provides technical and specialist support during the development phase of the device and, within its area of expertise, collaborates in defining the most suitable materials and, when necessary, in planning the digital processing, in accordance with the instructions received.
Continuous dialogue between the clinician and the laboratory allows the prescription to be translated into a feasible, functional and safe device, optimising comfort, reliability and final quality, in full compliance with current regulations and the laboratory’s quality standards.

Produzione, controlli e realizzazione del dispositivo medico su misura

Production is carried out exclusively on the clinician’s prescription and follows operating procedures defined within the laboratory’s Quality Management System.
Each phase – from manual to digital processing, where applicable – is planned and controlled to ensure precision, reliability and consistency with the prescription.

Orthofan integrates traditional processes and advanced digital workflows selected according to the type of device and clinical requirements.
The use of technology is functional to the quality of the final result.

Yes. The device is subject to intermediate and final checks, carried out according to documented criteria.
These checks verify the device’s compliance with the prescription, the materials used and the laboratory’s quality standards.

As a producer of custom-made medical devices, Orthofan is responsible for the correct execution of the production process, the conformity of the device and the associated documentation, in compliance with Regulation MDR 2017/745.

Processing times, pick-up and delivery

Average production times depend on the type of device and the complexity of the case. Orthofan guarantees fast processing without compromising quality, with controlled design, production and final verification processes.

Yes, the laboratory collects and delivers directly to the clinician’s office within approximately 24 hours throughout Italy, and up to 48 hours for the islands or overseas shipments, always ensuring the integrity and protection of the devices.

Yes, all domestic and international shipments are trackable via reliable couriers, with secure packaging to ensure that devices arrive in perfect condition.

Technical advice and support for clinicians

The laboratory offers direct contact via telephone, Zoom, and other digital tools, allowing for discussion of complex cases or special customisations.

Yes, Orthofan provides post-production technical support for any adjustments, clarifications or issues with the devices.

Courses, formation and teaching activities

Yes, seminars, workshops and theoretical-practical courses are organised, focusing on new orthodontic techniques, materials and innovative devices.

Absolutely, the practical sessions take place at the laboratory workstations, allowing participants to immediately apply what they have learned.

Orthofan keeps dental technicians and clinicians up to date through courses, events and informative content published on the blog and the laboratory’s official channels.

Payments, invoicing and administrative matters

Yes. Before proceeding with production, a quote is always shared, which must be accepted by the clinician.

Payments can be made securely by bank transfer, with full traceability of transactions.

Orthofan issues regular tax documentation for each order, ensuring clarity and transparency for both clinicians and employees.

Contact details and methods of collaboration

The laboratory can be contacted by telephone, email or online form, with rapid responses to requests for information, quotations or clarifications.

Yes, clinicians can request personalised quotes and download technical documentation or forms directly from the website.

Orthofan promotes close collaboration, offering technical support, training and ongoing advice to ensure the highest quality of devices and patient satisfaction.

Sì. Orthofan collabora con Clinici su tutto il territorio nazionale e anche all’estero, garantendo gli stessi standard qualitativi e operativi.

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