ABSTRACT
In.the.overall.success.of.computer-controlled.products,.both.hardware.and.software. must.work.normally..In.fact,.software.is.an.important.element.of.modern.medical. devices..In.1984,.approximately.80%.of.all.major.medical.systems.contained.one.or. more.computerized.components.and.it.was.predicted.that.by.1990.almost.all.electrical.medical.devices.would.be.composed.of.at.least.one.computerized.part.1-3.Furthermore,.over.the.years,.the.size.of.software.used.in.medical.devices.has.increased.quite. dramatically;. for. example,. the. software. of. a. typical. cardiac. rhythm. management. device.is.made.up.of.approximately.half.a.million.lines.of.code.4
