Quality management largely happens in the background. Documentation, validation, audits, work that is never visible from the patient’s chair. The benefit, however, is direct: every implant placed is the end product of a controlled, verified and documented process, and its path can be traced back to the manufacturing batch. This is the foundation on which long-term predictability rests, and something you can also refer to when informing your patients.
Denti System has operated under a certified quality management system for more than 25 years. This step is therefore not the introduction of a previously missing system, but the continuation of decades of manufacturing and professional practice, with a new certification body. The logic of manufacturing, documentation and control remains unchanged. What has been placed on new foundations is the independent verification.
The decision was driven by international expansion. SGS is one of the most widely recognised certification bodies in the world, and its presence and acceptance make it easier to introduce products in a range of markets. Involving an internationally established certification body speeds up discussions with partners and authorities wherever Denti System products enter a new market.
ISO 13485 is the international standard for quality management systems for medical devices. It prescribes a process-based approach covering the entire product life cycle, from design through manufacturing to distribution, and extends to risk management, traceability, process validation, complaint handling and corrective actions. The standard is a baseline requirement for medical device manufacturers and forms the basis of CE marking and several international market access programmes.
It is worth noting that certification is not a one-off event. It can only be issued by an accredited, independent certification body, and once obtained, its validity is maintained through annual surveillance audits. The operation of the system is therefore under continuous external supervision.
We thank our dentists for their trust and support. The development and manufacturing of the Callus system continues on the same regulated foundation that this certification confirms.
