Braceras, I.Ipiñazar, E.De Maeztu, M. A.Alava, J. I.2024-07-242024-07-242008-11Braceras , I , Ipiñazar , E , De Maeztu , M A & Alava , J I 2008 , ' Risk analysis and implants ' , Medical Engineering and Physics , vol. 30 , no. 9 , pp. 1201-1204 . https://doi.org/10.1016/j.medengphy.2008.04.0011350-4533https://hdl.handle.net/11556/4336According 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.4enginfo:eu-repo/semantics/restrictedAccessjournal article10.1016/j.medengphy.2008.04.001Clinical studyDental implantIon implantationMedical Device DirectiveRisk analysisBiophysicsBiomedical Engineeringhttp://www.scopus.com/inward/record.url?scp=55949103755&partnerID=8YFLogxK