Mezzovico-Vira, 26th May 2021 – SmartBone ® On Demand™, our custom-made service is MDR certificated according to the Medical Device Regulation 2017/745.

After months of hard-working that engaged the whole IBI’s team our custom-made service obtained the MDR certification by Notified Body BSI.

Another important goal that confirms that our personalized bone grafts are fully compliant with the most rigorous controls on health and safety related to the quality assurance for being put into the medical devices European market.

Following the new regulation we updated our brochure related to the custom-made, that you can download HERE.

Moreover, we also implemented an Implant Card related to the custom-made grafts, it consists in a handy double card with general information such as personal details and information about the operation that the doctor who performed the surgery must fill. This card must carry all the time by the patient.

We suggest checking our page dedicated to the implant card: https://www.ibi-sa.com/implant-card/

If you are looking for further information about SmartBone ® On Demand™, please visit the related product page: