A Development Life Cycle Process for Data-Driven Artificial Intelligence-enabled Software as a Medical Device

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This work is being undertaken by Karla Aniela Cepeda Zapata

The use of AI is becoming integral to today's society. Despite the benefits and opportunities of AI technology in medical devices, concerns can arise from its design and development approach. Regulations and standards published by ISO and IEC organisations play a relevant role in maintaining the safety of patients and intended users. Karla's project examines the life cycle of AI-enabled software as a medical device, considering AI-specific activities, best practices, and regulations to support manufacturers in ensuring AI-enabled systems remain safe.

Karla is supervised by Prof. Fergal McCaffery, Dr Róisín Loughran and Prof. Tomás Ward (DCU)

This project is funded through the Technological University Transfer Fund (TUTF) and DkIT.