title: Considering risk.
abstract: Medical device manufacturers have to go to a lot of effort before they can bring a new product to market. Even when the product is on the market there are many things to consider to keep it there. These efforts are deemed worth making, because they believe that there will be a "return on investment." In many cases this expectation proves to be right, sometimes it does not. They must be prepared to take some risk. This article discusses the regulated environment in which research into (new) medical devices takes place and the management of regulatory risk.
authors.affiliation: Sorin Biomedica Nederland NV, Utrecht, The Netherlands.
authors.forename: G
authors.initials: G
authors.lastname: Reichman
mesh_terms: D004867:Equipment Design / Q000592:standards; D004868:Equipment Failure; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D007221:Industry / Q000592:standards*; D008420:Manufactured Materials / Q000592:standards*; D009426:Netherlands; D012308:Risk Management / Q000458:organization & administration*