OrthoTrack is the first traceability software for custom-made medical devices in orthodontics. It secures your practice by ensuring compliance with the European MDR 2017/745 regulation. With its integrated scheduling, it organizes your in-house lab and centralizes traceability into a single, simple, and connected tool.
https://www.youtube.com/watch?v=6oTurM7gESE
OrthoTrack presentation video
Duration: 1 min 22 sec
Software for certification of your CMDs and traceability of your products
Optimize the management of your custom-made medical devices (CMDs) with our orthodontics-focused software. It allows you to certify your CMDs in compliance with MDR 2017/745 and ensures full traceability of products, materials, and batches. Simple, secure, and compliant, it centralizes all essential data for rigorous tracking and complete peace of mind.
In-house scheduling for your lab
No more wasted time juggling sticky notes, notebooks, or scattered Excel files. With OrthoTrack, every step of the production process is centralized in one clear and efficient tool. You can confidently delegate traceability management to your assistants while maintaining full control and security over your organization.
Custom-made medical devices 3D printed
What is it in theory?
Definition of a Custom-Made Medical Device (CMD)
According to EU Regulation 2017/745, applicable since May 26, 2021, a custom-made device is defined as a device specifically manufactured following a written prescription from a person authorized under national law, by virtue of their professional qualifications. This prescription specifies the design characteristics under the prescriber’s responsibility, and the device is intended for a specific patient, in response to their needs and medical condition (Public Health Code, Article R5211-6). Manufacturers of CMDs must follow the procedure described in Annex XIII of Regulation 2017/745.
Requirements for 3D-Printed CMDs
3D-printed CMDs must comply with several requirements:
- Safety and compliance: Devices must be safe and meet regulatory expectations.
- Qualified procedure: This includes risk analysis and verification of the biocompatibility of the materials used.
- Documentation: Manufacturers must provide documentation proving that these requirements have been met.
Compliance and Declaration
If the CMD meets the definition set out in Article R5211-6 of the Public Health Code, the manufacturer is not required to assign a device classification. However, the manufacturer must provide a CE declaration of conformity for each device produced, ensuring that all relevant standards and regulations have been met.
YES in everyday orthodontic practice?!
In-office aligners
Study models (resin or plaster)
Retention aligners
Direct or indirect retention wires (bonding protocol)
Orthosurgical guides
Indirect bonding trays
Appliances made directly in the mouth
Appliances made in the practice laboratory
Mandibular splints + mouthguards
Protect your orthodontic practice!
By manufacturing your own custom-made medical devices (aligners, retainers, wires, surgical guides, etc.), you are legally considered a manufacturer. As such, traceability is mandatory under European Regulation 2017/745. Without proper traceability, your practice is exposed to various risks.
50
%
Reduction in the average certification time of orthodontic devices
99
%
Regulatory compliance rate achieved through the use of OrthoTrack
80
%
Increase in the practice’s operational efficiency
Tests and analyses conducted with OrthoTrack users
Compatible with all machines
OrthoTrack adapts to your existing equipment. Thermoforming machines, 3D printers, 3D retainer bending machines, digital intraoral scanners…
Integrations with your practice software
OrthoTrack integrates seamlessly into your daily workflow thanks to its connections with your practice software.
👉 Result: a smooth workflow with no duplicate data entry.
1 single subscription
that protects your entire practice
- Unlimited practitioners
- Unlimited patients
- Unlimited workstations
No hidden fees, no usage limits
Configurable, customizable, and adaptable to all types of orthodontic practice
The OrthoTrack Store
49,90€ / month
- Certification of your custom medical devices
- Traceability of products used for custom-made medical devices
- Certificate history
- Updates included
- Production planning for your custom-made medical devices (internal lab organization)
- Comprehensive patient database
1 month free
548,90€ / year
- Certification of your custom-made medical devices
- Traceability of products used for CMDs
- Certificate history
- Updates included
- Production planning for your CMDs (internal lab organization)
- Comprehensive patient database
Instant activation
7-day trial period
Secure payment with encryption
Easy cancellation (no commitment)
Technical and commercial support
Unlimited updates included
