Highly aesthetic prosthetic solutions
using CAD/CAM technology
The preparation of prosthetic parts (so-called custom-made products) on the basis of the provided data for the supply of OKTAGON® Implants takes place under own responsibility taking into account the relevant requirements of the Medical Devices Directive 93/42/EEC.
The manufacturer is committed to provide technical support in assessing incidents (near-incidents, information about injuries to people, etc.) and customer complaints in relation with the use of the manufactured products, and jointly take corrective measures such as recall actions and subsequent further corrective actions, define, implement and inform each other. The costs for the implementation of the respec
The manufacturer is therefore responsible for the quality (reliability, accuracy of fit) of the created OKTAGON® products as well the compliance with the relevant requirements of the above-mentioned guideline. If industrial property rights of third parties are violated during manufacture and delivery, it is in the responsibility of the manufacturer. In order to enable the quality of the manufactured parts, up-to-date technical data and information on the prosthetic interface of the implants are made available. These specifications are confidential. These are to be used exclusively in the context of the treatment of OKTAGON® Implants. This information may not be disclosed to third parties.