Many dental practices assess a dental laboratory on the basis of lead times, cost or the perceived quality of the device. However, there is a less obvious factor that affects the safety and reliability of the partnership: the system by which that device is designed, manufactured and inspected.
BEYOND THE DEVICE: THE VALUE OF THE PROCESS
In modern dentistry, precision, safety and regulatory compliance are increasingly key factors in the choice of a laboratory partner. When a medical device is fitted to a patient, the clinical outcome depends not only on the design and manufacture of the device, but also on the reliability of the processes that have ensured its quality.
For this reason, ISO 13485 certification is now one of the key indicators of reliability for an orthodontic laboratory.
This is the specific international standard for quality management systems for medical devices, developed to ensure process control, traceability, risk management and compliance with European regulatory requirements.
FULL TRACEABILITY OF MEDICAL DEVICES
Every device manufactured in a certified orthodontic laboratory is accompanied by documentation that identifies the materials, production batches, suppliers and manufacturing stages.
This traceability makes it possible to quickly retrieve all the necessary information in the event of document checks, patient enquiries or inspections by the relevant authorities.
QUALITY CONTROL AND RISK MANAGEMENT
“Quality is not about catching an error when it occurs, but about designing processes that reduce the probability of it.”
As already explained on the Quality System page, every medical device must undergo rigorous process controlfrom design to production, right through to final checks. Risk analysis is integrated into every stage, allowing any critical issues to be prevented and ensuring compliance with safety and functionality standards.
Risk management and material traceability also enable clinicians to always have reliable devices, minimizing the possibility of deviations from established protocols.
COMPLIANCE WITH THE MDR REGULATION 2017/745
The introduction of the European Medical Devices Regulation (MDR) 2017/745 has significantly raised the standards required of medical device manufacturers.
An ISO 13485-certified laboratory employs structured and continuously monitored procedures to ensure compliance with current regulations, offering dental practices a reliable partner in managing the documentation and quality aspects of production.
WHAT DOES THIS MEAN IN PRACTICAL TERMS FOR A DENTAL PRACTICE?
APPEARANCE | ISO 13485 CERTIFIED PROCESS | NON-CERTIFIED PROCESS |
Traceability | ✅Documented and verifiable procedures | ❌ Variable modalities from laboratory to laboratory |
Quality control | ✅ Controls defined and recorded | ❌ Depending on the internal procedures adopted |
Non-conformity management | ✅ Formalized and documented process | ❌ Management not necessarily standardized |
Regulatory compliance | ✅ System designed to comply with MDR 2017/745 | ❌Variable level of structuring |
Continuous improvement | ✅ Audits and periodic checks | ❌ External controls are not always foreseen |
QUALITY IS NOT SEEN WHEN EVERYTHING WORKS
A dentist receives a quality device if:
- arrives on time;
- it is compliant;
- the documentation is correct;
- the material is as declared;
- traceability is available;
- no problems occur;
The Quality System therefore becomes invisible.
Certification serves to ensure that all these aspects become normal and predictable.
QUALITY AS VALUE
Collaborating with a certified orthodontic laboratory therefore means relying on an organization that operates according to verified procedures, documented controls, and internationally recognized regulatory requirements. This value goes beyond the manufactured device and contributes to the overall quality of the treatment.
Orthofan has chosen to adopt and maintain an ISO 13485 certified management system because it believes that the quality of a medical device begins long before its delivery.
