Observations on medical device design, Part II: Good practice.
Current guidance on design is inadequate. This second article in a two-part series presents a framework for good design practice that attempts to improve designers' awareness of manufacturing and validation issues. Seven design tactics, derived from observations of current industry practice and design literature, seek to encourage good practice and achieve safer, more profitable devices.
Alexander
K
K
Cambridge Engineering Design Centre.
Clarkson
J
J
Bishop
D
D
D004867:Equipment Design; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000145:classification / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D018570:Risk Assessment