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Standard IEC 62304 - Medical device software - Software lifecycle processes
Abstract
IEC 62304, if accepted, requires what reputable medical device manufacturers are already doing. The author therefore expect them to welcome it. It would remove the obligation to describe their processes in detail in regulatory submissions to the FDA. With all its limitations, the author commends IEC 62304. There are still medical device manufacturers whose software development processes are quite rudimentary, and this threatens the lives of patients. IEC 62304 will prevent this and provide a more level playing field for all medical device manufacturers. There appears to be no appetite among either medical device manufacturers or regulators for a more extensive standard prescribing methods and techniques. Holding out for more at this stage would ensure that we get nothing. IEC 62304 also takes a big step towards simpler and more uniform expectations on both sides of the Atlantic.
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“Indeed, the FDA has acknowledged that its traditional paradigm for device regulation was not designed for continuously learning AI/ML systems [62,63,73].”
From A Review of Multi-Agent AI Systems for Biological and Clinical Data Analysis (2026) · cites this paper as [63]
In the citing paper
“AIPM software developers are recommended to follow relevant existing international standards with regard to software testing, such as the IEC 62304:2006117, the IEC 82304-1:2016118, IEC 62366-1:201598, ISO 14971:2019119, Food and Drug Administration principles of software validation120, and Food and Drug Administration guidance for off-the-shelf software use in medical devices121.”
From Guidelines and quality criteria for artificial intelligence-based prediction models in healthcare: a scoping review (2022) · cites this paper as [117]
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de Hond, A. A. H., Leeuwenberg, A. M., Hooft, L., Kant, I. M. J., Nijman, S. W. J., van Os, H. J. A., Aardoom, J. J., Debray, T. P. A., Schuit, E., van Smeden, M., et al. (2022) · npj Digital Medicine · doi:10.1038/s41746-021-00549-7 · Cited by 499
Operationalised product quality models and assessment: The Quamoco approach
Wagner, S., Goeb, A., Heinemann, L., Kläs, M., Lampasona, C., Lochmann, K., Mayr, A., Plösch, R., Seidl, A., Streit, J. J., et al. (2015) · Information and Software Technology · doi:10.1016/j.infsof.2015.02.009 · Cited by 114
Fosch‐Villaronga, E., & Mahler, T. (2021) · Computer law & security review · doi:10.1016/j.clsr.2021.105528 · Cited by 112
Conditional Safety Certification of Open Adaptive Systems
Schneider, D., & Trapp, M. (2013) · ACM Transactions on Autonomous and Adaptive Systems · doi:10.1145/2491465.2491467 · Cited by 99
Industry needs and research directions in requirements engineering for embedded systems
Sikora, E., Tenbergen, B., & Pohl, K. (2011) · Requirements Engineering · doi:10.1007/s00766-011-0144-x · Cited by 83
Metadata
- Authors
- Jordan, P.
- Corresponding author
- Jordan, P.
- ORCID
- Jordan, P.
- Venue
- IET Seminar on Software for Medical Devices
- Publisher
- IEE
- Published
- 2006
- Volume
- 2006
- Pages
- 41-47
- OpenAlex
- W2037889871
- Cited by
- 244
- References
- 0
- Citations by year
- 2026: 45 · 2025: 21 · 2024: 15 · 2023: 12 · 2022: 17 · 2021: 15 · 2020: 6 · 2019: 5 · 2018: 4 · 2017: 12 · 2016: 14 · 2015: 14 · 2014: 14 · 2013: 13 · 2012: 11
- FWCI
- 8.32
- Type
- conference paper
- Language
- en
- Open access
- closed
- Topics
- Physical Sciences › Engineering › Safety, Risk, Reliability and Quality › Safety Systems Engineering in Autonomy
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Regulation
- Physical Sciences › Computer Science › Information Systems › Software Engineering Techniques and Practices
- Keywords
- IEC 62304, medical device software, medical device regulation, FDA regulatory submissions, software development process, software safety standards, international regulatory harmonization
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