Medical Software Quality Assurance


This page contains information on software development methodology generally, with special reference to spreadsheets.

For more information on 'spreadsheets as proper software', visit


Information on an Excel spreadsheet for GFR calculation is also available on this site.





Recently published guidance from the Informatics and Computing Special Interest Group of the IPEM:


A series of articles on aspects of in-house software development are being published in Scope; the first two of which have already appeared:


1. Trouncer R. Writing quality software: setting the scene. Scope, Dec 2015, pp 22-23


2. Cosgriff PS et al. In-house development of medical software: Regulations and standards. Scope, March 2016, pp 23-26


A more detailed version of the published article (including a full reference list) is available for download from the IPEM website:


The next article in the series (Software Testing) will be published in the June 2016 issue.



PDF files available for download: most recent at the top..



NOTE: If you just click the links below, the document will open within your web browser (not recommended).

It’s better to right-click on the link and select Save Target As...

You will then get the normal ‘save file’ dialogue box.

When the file is downloaded it will just open within your PDF viewer (if installed) when you double-click it.


The PDF files are ‘protected’. You can view/print but will not be able to copy/paste.




IPEM Report 111 and associated issues:


A Chapter on ‘In-house development of medical software’ was originally intended to be included in the revision of IPEM Report 86 (Quality Control of Gamma Camera Systems).

The updated report has now been published as IPEM Report 111 (Quality Control of Gamma Cameras and Nuclear Medicine Computer Systems).


Two sections* of the original chapter have been retained in IPEM 111, but it was decided that most of the content should be generalised and published by the ICSIG (see above).

The complete work is made available here, until such time as the complete series of articles in production by ICSIG is published.

For specific information on regulations and standards please refer to the ICSIG article referenced above, as it has been updated more recently.

In-house development of medical software v1.3 (May 2015) – 643KB


* Testing of commercial software and management of software upgrades.


With regard to the legal issues, the opinions and interpretations expressed are my own.

©Normal copyright protection applies.

NOTE: This is a long document (61 pages), so please think before printing.



Miscellaneous presentations


Most of the files below are presentations given by myself (PSC) at various UK meetings, most recent at the top.

Extra slides and information are provided that were not presented at the meetings.

One or two presentations were given by others and are provided here (with permission) as they are not available elsewhere.


Note: Since early 2015, all presentations given at IPEM meeting are available (to members) as PowerPoint PDFs on the IPEM website.


If you refer back to older presentations please note that specific comments about regulations were only relevant at that time.

For example, the UK's Medical Device Regulations have been revised several times since their introduction (most recently in March 2010) so

always obtain the most up to date picture from the MHRA website.


The software medical device: A review of regulations  [314 KB]

P.S.Cosgriff. Medical Physics and Engineering (MPEC) Annual Conference, Glasgow, September 2014.


Applying standards to in-house developed software – an experience to be shared  [1.3 MB]

D.W.Jennings, G. Dempsey. IPEM meeting: Bespoke Software in Medical Physics & Clinical Engineering, London, May 2012.

By kind permission of David Jennings, September 2015.

This article is reproduced here as it wasn’t referred to in the corresponding meeting report published in Scope 2012: 21: 23-25.

It is referred to in the ICSIG guidance on regulation and standards (see above.


In house development and distribution of clinical software: A view from nuclear medicine  [1.7 MB]

P.S.Cosgriff, Joint IPEM/ISMRM* meeting: It’s a risky business: use of off-label and non CE marked software and hardware in the research and clinical setting.

Nottingham University, 1 September 2010. *International Society of Magnetic Resonance in Medicine (British chapter)


Open source software for in-house development of medical software?  [5.5 MB]

P.S.Cosgriff. IPEM meeting: Can open source software be used for clinical work?, London, 7 November 2007.


A developer's perspective on the legal issues surrounding the in-house production of medical software  [1.9 MB]

P.S.Cosgriff. IPEM Meeting: The Software Medical Device, London, 12 November 2004.


Spreadsheets: The 'Cinderella' of medical software

P.S.Cosgriff. IPEM meeting: Quality assurance for in-house and bespoke software, 3 October 2002

There is a choice of download for the above presentation (converted from Powerpoint to PDF)

Full colour slides with associated notes (one slide/page) [2.6 MB]

Greyscale slides without associated notes for mono laser printing (6 slides per A4 page) [2.7 MB]


Basic guidelines for writing spreadsheets  [1.6 MB]

P.S.Cosgriff. BNMS Annual Meeting, April 2002


The "software process" - applied common sense or overkill?   [62 KB]

P.S.Cosgriff. IPEM Systems Engineering Meeting, March 1998.


Quality assurance of software used in diagnostic medical imaging  [12 KB]

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


Quality assurance of medical software  [61 KB]

P.S.Cosgriff. Journal of Med Eng and Tech, Volume 18, No 1, pp1-10, 1994.


This page was last updated on 30 March 2016

Address for correspondence:

 Nuclear Medicine Department, Pilgrim Hospital, Boston, PE21 9QS, UK

 E-mail to

You will find related information at the following sites:


UK Safety Critical Systems Club

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