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...View metadata citation and similar papers at core ac uk brought to you by provided stor creation of an iec compliant software development plan peter rust derek flood fergal mccaffery dkit ie abstract organizations engaged in medical device are required demonstrate compliance with a set standards regulations before the can be marketed one such standard life cycle pro cesses defines processes that order develop safe demon strating problematic for new or have limited experience domain what must carried out but does not state how review number organisations it was found proved difficult task this work we created template assist arduous will validated these as part future keywords regulatory process improvement roadmaps introduction devices been around centuries is only last decades twentieth cen tury has become widespread operation control some kinds de vices because critical nature due increase recalls arising from failures bodies acted try andrectify growing trend address issues internat...