title: A risk assessment and control model for the failing Björk-Shiley convexo-concave heart valve.
abstract: For risk assessment and control of the failing Björk-Shiley convexo-concave heart valve, we present a life cycle-based complex system model and a risk intensity assessment model, allowing consistent analysis of this complex medical problem and identification of all pertinent aspects of product-related risks to patients.
authors.affiliation: Delft University of Technology, University of Amsterdam.
authors.forename: F
authors.initials: F
authors.lastname: Koornneef
authors.forename: G L
authors.initials: GL
authors.lastname: van Gaalen
authors.forename: B A
authors.initials: BA
authors.lastname: de Mol
mesh_terms: D004867:Equipment Design; D004868:Equipment Failure; D004869:Equipment Safety; D006350:Heart Valve Prosthesis / Q000592:standards*; D006801:Humans; D008962:Models, Theoretical; D018570:Risk Assessment; D013673:Technology Assessment, Biomedical / Q000379:methods*