Medical software design standard IEC 62304 came into force in June 2010 and is now regulatory. Triteq Technical Director Ken Hall, was asked to share his views by emdt magazine and his article describes how the standard will impact the software development process for medical device manufacturers.
Standards for medical device design
“Until recently, safety regulations for medical device software, at least formally, were not exceptionally rigorous across the board. In addition, software was not formally classified as a medical product by the Medical Devices Directive. This has now changed. A new regime is in force governing all medical device software development for all classes of device.”