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Manufacturing of medical devices is strictly controlled by authorities, andmanufacturers must conform to the regulatory requirements of the region inwhich a medical device is being marketed for use. In general, theserequirements make no difference between the physical device, embedded softwarerunning inside a physical device, or software that constitutes the device initself. As a result, standalone software with intended medical use isconsidered to be a medical device. Consequently, its development must meet thesame requirements as the physical medical device manufacturing. This practicecreates a unique challenge for organizations developing medical software. Inthis paper, we pinpoint a number of regulatory requirement mismatches betweenphysical medical devices and standalone medical device software. The view isbased on experiences from industry, from the development of all-softwaremedical devices as well as from defining the manufacturing process so that itmeets the regulatory requirements.

On Medical Device Software CE Compliance and Conformity Assessment