Cited by 245Safety Systems Engineering in AutonomyHealthcare RegulationSoftware Engineering Techniques and Practices

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Standard IEC 62304 - Medical device software - Software lifecycle processes

Jordan, P.·2006·IET Seminar on Software for Medical Devices

DOI 10.1049/ic:20060141

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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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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
DOI: 10.1049/ic:20060141
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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Standard IEC 62304 - Medical device software - Software lifecycle processes

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