Risk analysis and implants.

摘要

According to the Medical Devices Directive, both the preparation for clinical trials and marketing of implants require that a risk analysis is performed. This paper presents a risk analysis for a dental implant in the framework of the risk management process carried out for the preparation of a multi-centre clinical trial, where likely hazards, failure modes and their severities, probabilities and detectabilities are assessed, together with a review of the related scientific literature. The clinical study aimed to evaluate a new ion implantation-based implant surface designed for the promotion of more extensive and faster osseointegration.