Publications
The recent publications listed below contain general guidance on the software development process, plus specific regulatory requirements for software (including AI) that qualifies as a medical device.
1. Cosgriff PS, Memmott M. Writing in-house medical device software in compliance with EU, UK and US regulations. CRC Press, 2024. Order here.
Note: The above book has an associated free Supplementary Materials file that includes a list of all the references in the book as clickable hyperlinks. The PDF (version 2.7) is available from the publisher's website, but it is also available for download here. It will be updated before the end of 2025.
2. Cosgriff PS, Memmott M. Artificial intelligence in radiology. Scope, 2021: 31:2: 36-39. See IPEM website for access.
3. Cosgriff PS. Regulatory considerations when deploying your software in a clinical environment. In: Diagnostic Radiology Physics with MATLAB, CRC Press, 2020. Order here.
Forthcoming publication..
A new book proposal on the application of AI techniques to the software medical device development process was accepted by CRC Press in March 2025. The provisional title is Development and Regulation of Artificial Intelligence as a Medical Device.
It is planned as a 18 month project, due to be completed in September 2026. My co-author is Prof. Giulio Mallardi, Department of Computer Science, University of Bari, Italy. The publication will cover all the AI-related material on this website in a lot more detail.
