NEW PROJECTS

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 "Using Artificial Intelligence to Assist the Development of Medical Device Software". 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.

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PREVIOUS PUBLICATIONS

The publications listed below (most recent at top) contain general guidance on the software development process, plus specific regulatory requirements for software that qualifies as a medical device.

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Cosgriff PS, Memmott M. Writing in-house medical device software in compliance with EU, UK and US regulations. CRC Press, 2024. (More details on this publication can be found on a separate page).​​​​​​​​​

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​Cosgriff PS, Memmott M . Artificial intelligence in radiology. Scope, 2021: 31:2: 36-39. See IPEM website for access.

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Cosgriff PS. Regulatory considerations when deploying your software in a clinical environment. Diagnostic Radiology Physics with MATLAB, CRC Press, 2020. (This chapter covers both EU and US medical device regulations). Order here.​​​

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A series of articles were published in 'Scope' (the official journal of the Institute of Physics and Engineering in Medicine, IPEM) during the period 2015-2017. The articles were written by a software development working party set up by the Informatics and Computing Special Interest Group (ICSIG) within IPEM:

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• Writing quality software: Scope, 2015: 24: 4: 22-23

• In-house development of medical software. Scope, 2016: 25: 1: 23-26. Download PDF

• The case for software testing. Scope, 2016: 25: 2: 20-22.

• The software lifecycle: common methodologies. Scope, 2016: 25: 3: 23-26.

• Project initiation and management. Scope, 2017: 26: 2: 10-13.

• Requirements specification. Scope, 2017: 26: 3: 12-14.

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The references below are provided mainly for historical interest, but they contain basic information and advice that is still relevant today.

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Quality assurance of in house developed software in nuclear medicine [409 kB]. Download PDF (TBA)

P.S.Cosgriff & A. Houston, published in 2003 in IPEM Report 86: 'Quality control of gamma camera systems'

 

[The above book is now out of print. It was replaced by IPEM Report 111 in 2015, but the chapter on software was limited to the testing of commercial software - due to the work of the ICSIG referred to above]. 

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Basic guidelines for writing spreadsheets [3.0 MB]. Download PDF (TBA)

P.S.Cosgriff. Presented at the Annual Meeting of the British Nuclear Medicine Society, April 2002

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Quality assurance of software used in diagnostic medical imaging [12 kB]. Download PDF (TBA)

P.S.Cosgriff. Safety Systems, Vol 5, No 2, 1996.

 

Quality assurance of medical software  [61 kB]. Download PDF (TBA)

P.S.Cosgriff. Journal of Medical Engineering and Technology, Volume 18, No 1, pp 1-10, 1994.

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​Note that more selected articles (by other authors) are provided in the downloads area​​​​

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This page last updated: 24 May 2025​

 

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