On Medical Device Software CE Compliance and Conformity Assessment

• URL: http://arxiv.org/abs/2103.06815v1
• Date: Thu, 11 Mar 2021 17:35:40 GMT
• Title: On Medical Device Software CE Compliance and Conformity Assessment
• Authors: Tuomas Granlund, Tommi Mikkonen and Vlad Stirbu
• Abstract summary: Manufacturing of medical devices is strictly controlled by authorities. 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.
• Score: 4.910937238451484
• License: http://arxiv.org/licenses/nonexclusive-distrib/1.0/
• Abstract: 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.

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