Quality Management System
ISO 9001 AND ISO 13485 CERTIFICATIONS
Quality Management System in the Orthofan Orthodontic Lab
Orthofan’s Quality Management System is at the core of our business: every Custom-Made Medical Device is designed and manufactured according to rigorous, certified, and documented processes. This approach guarantees safety, reliability, and traceability, providing clinicians with concrete tools for treating patients and enhancing every stage of production.
Quality as a core value of Orthofan
For Orthofan, quality is not just a regulatory requirementbut a fundamental value. Every decision, every process, and every device is designed to ensure precision, safety, and reliability. The combination of technical expertise, innovation, and ongoing staff training also allows us to offer tailor-made devices of the highest standard, always in compliance with international standards.
A reliable Quality Management System ensures that laboratory activities are organized, controlled, and documented, thereby reducing operational uncertainties and guaranteeing a clear path from design to delivery of the device.
ISO 9001 and ISO 13485 certifications in the Orthofan Lab
Orthofan is certified to both ISO 9001 and ISO 13485 standards.which means that every stage of the production of custom-made medical devices is monitored and documented. These certifications therefore guarantee compliance with international quality and safety requirements, ensuring that processes are constantly improved and auditable.
ISO certifications represent a guarantee of reliability for clinicians, reducing the risk of errors and increasing patient safety.
Compliance with Regulation MDR 2017/745 and manufacturer responsibility
Orthofan operates in full compliance with Regulation MDR 2017/745, which defines the rules for the design and manufacture of custom-made medical devices. The adoption of these guidelines also ensures that each device is safe, efficient, and properly documented, protecting both the patient and the clinician from a medical-legal standpoint.
The Laboratory’s responsibility as a manufacturer means that every device is produced according to strict standards, with full traceability and regulatory compliance.
Process control and risk management in custom-made medical devices
Every medical device manufactured in the Orthofan laboratory is ultimately subject to rigorous process control.from 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.
Traceability, documentation, and final checks of the custom-made medical device
Finally, each Orthofan device comes with complete documentationthat allows every stage of production to be traced: materials used, tests performed, protocols followed. Multiple final checks are carried out to ensure that the product delivered fully complies with clinical indications and safety requirements.
Traceability and structured documentation are essential tools for clinicians, offering transparency and safety at every stage of treatment.
Continuous improvement and a culture of quality at Orthofan
Continuous improvement is a key principle of our Quality Management System.. Orthofan constantly invests in training, updating, and technological innovation, integrating new methodologies and tools to optimize processes and increase device reliability.
A strong culture of quality not only strengthens the laboratory internally, but also creates tangible benefits for clinicians by facilitating communication, improving case management, and increasing patient satisfaction.
Why the Quality Management System is an advantage for clinicians
Real value for clinicians and patients
Relying on a laboratory structured according to a certified Quality Management System means being able to count on a reliable partner who is aware of their responsibilities and capable of operating in full compliance with regulations.
The Quality Management System reduces operational uncertainties, improves communication between clinicians and laboratories, and enables more effective case management, from initial prescription to device delivery. For patients, this means safe, reliable devices that are consistent with the established treatment plan.
