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.

翻译：医疗设备的制造受到当局的严格控制,制造商必须符合正在销售医疗设备的区域的管理要求;一般而言,这些要求对物理装置、在物理装置内运行的嵌入软件或构成该装置本身的软件没有区别;因此,将具有预期医疗用途的独立软件视为医疗装置;因此,其开发必须符合与物理医疗装置制造相同的要求;这种做法对开发医疗软件的组织构成独特的挑战;在本文件中,我们明确了物理医疗装置和独立医疗装置软件之间的一些管理要求不匹配之处;这种观点基于工业的经验,从开发所有软件医疗装置到确定制造过程,使之符合管理要求。