Addressing the AI-enabled Medical Device Software Development Life Cycle: A Review and Integration of IEC 62304 and ISO 5338

Cepeda Zapata, Karla Aniela and Haider Janjua, Zaffar and Loughran, Roisin and Ward, Tomas and McCaffery, Fergal Addressing the AI-enabled Medical Device Software Development Life Cycle: A Review and Integration of IEC 62304 and ISO 5338. DCU press. (Submitted)

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Abstract

International standards are essential for harmonising best practices to ensure the quality of products and services. IEC 62304 is a recognised reference standard for defining development life cycle (DLC) activities for medical device software (MDS). However, given the growing adoption of AI within this sector, it is essential to embed AI-specific requirements to guide the development of AI-enabled Medical Device Software (AIeD). As part of previous work, this paper reviews and maps IEC 62304:2006+A1:2015 and ISO/IEC 5338:2023, a process standard that provides generic life cycle pro-cesses for AI systems. These two standards are derived from ISO/IEC/IEEE 12207 and share elements that can be integrated to propose an initial DLC framework for AIeD. The integration involves joining process IDs and identifying relevant keywords from each activity/task. Fourteen processes from ISO 5338 are aligned across activities in the IEC 62304 development pro-cess, including two AI-specific processes: Data Engineering and Knowledge Acquisition. Additionally, +11 AI-specific tasks and +24 AI-specific guidelines are identified and aligned. Future work will incorporate additional relevant standards and regulatory considerations to further detail and support this framework. Lessons from this paper could stimulate future research to auto-mate the integration of standards, thereby enabling easier compliance for MDS manufacturers.

Item Type:	Article
Subjects:	Computer Science > Computer Software
Research Centres:	Regulated Software Research Centre
Depositing User:	KarlaAniela CepedaZapata
Date Deposited:	17 Dec 2025 08:21
Last Modified:	17 Dec 2025 08:21
License:	Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI:	https://eprints.dkit.ie/id/eprint/983

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