  Manufacturing of medical devices is strictly controlled by authorities, and
manufacturers must conform to the regulatory requirements of the region in
which a medical device is being marketed for use. In general, these
requirements make no difference between the physical device, embedded software
running inside a physical device, or software that constitutes the device in
itself. As a result, standalone software with intended medical use is
considered to be a medical device. Consequently, its development must meet the
same requirements as the physical medical device manufacturing. This practice
creates a unique challenge for organizations developing medical software. In
this paper, we pinpoint a number of regulatory requirement mismatches between
physical medical devices and standalone medical device software. The view is
based on experiences from industry, from the development of all-software
medical devices as well as from defining the manufacturing process so that it
meets the regulatory requirements.
