Development and Marketing of Medical Devices

News / i3DPectus Prothesis CE Approval

The the iSurgical3D obtained CE certification of the prosthesis i3DPectus for correction of Pectus Excavatum by the Nuss. (link).

This certification from the Infarmed CA (Competent Authority) certifies the knowledge and competence of the company and its employees to develop advanced clinical solutions.

In this process, had the collaboration the iSurgical3D of Infarmed ON (Notified Body), which requested the assessment of conformity. This process was indeed the first of its kind conducted by this agency.

Thus, the iSurgical3D might have to start providing the complete solution for this condition and surgical instruments for placement and future removal of the prosthesis.


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