A Review of AI Life Cycle-related Standards to Address AI-enabled Medical Device Development

Cepeda Zapata, Karla Aniela and Loughran, Roisin and Ward, Tomás and McCaffery, Fergal (2026) A Review of AI Life Cycle-related Standards to Address AI-enabled Medical Device Development. Systems, Software and Services Process Improvement. ISSN 1865-0929

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Abstract

The integration of Artificial Intelligence (AI) in Medical Device Software (MDSW) can bring opportunities to enhance clinical workflow. However, this has also brought challenges to manufacturers, of which additional considerations during the development process must be contemplated. As an initial step to address the development of AI-enabled Medical Device (AIeMD), this review paper aims to identify relevant AI Standards for an initial under-standing and propose an alignment of the development life cycle (DLC) of MDSW and AI systems. Standards are resources to harmonise best practices, some of which are also accepted to address aspects of MDSW. In the AI domain, standardisation work is a key ongoing process to ensure the responsible development of AI systems. ISO/IEC 5338 provides a life cycle framework for AI systems; however, identifying related standards is essential to consider consistent use of processes, stages, activities, and terminologies. As numerous AI Standards have been published in recent years, the most relevant AI Life Cycle-related standards are identified through the AI Stand-ards Hub (AIHub). A set of criteria is established to select standards that cover the DLC of AI systems, including standards associated with the data management life cycle. The search on AIHub brought 33 AI-specific standards, most of which were issued by ISO/IEC. After cross-validation, the standards were inspected to identify additional standards not included in the AIHub results, resulting in four more being added to the list. After data selection, eleven AI life cycle-related standards were chosen towards implement-ing a framework for the DLC of AIeMD.

Item Type:	Article
Subjects:	Computer Science > Computer Software
Research Centres:	Regulated Software Research Centre
Depositing User:	KarlaAniela CepedaZapata
Date Deposited:	17 Dec 2025 08:19
Last Modified:	17 Dec 2025 08:19
License:	Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI:	https://eprints.dkit.ie/id/eprint/982

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