AI and health: Achieving regulatory compliance
Healthcare is emerging as a prominent area for AI applications, but innovators aiming to seize this chance face one major issue: achieving regulatory compliance.
Using a real industry case study, Gloria Macia walks you through the current American and European regulatory frameworks for medical devices and provides a step-by-step guide to market for AI applications, highlighting the main challenges and pitfalls to avoid as well as the key issues a company needs to consider to succeed in this endeavor.
Gloria Macia is a data scientist at the Diagnostics Data Science Lab at Roche AG, where she works to bring data-driven solutions to the market. Previously, she was part of the quality and clinical affairs management team at Sonova AG. Her interests include AI, translational science, medical device development, and healthcare regulation. Gloria came to Switzerland in 2015 for a research stay at the Institute of Bioengineering from EPFL and later decided to pursue a MSc in biomedical engineering-bioelectronics at ETH Zurich. Her computer science skills have been awarded several prizes and scholarships from renowned companies such as Intel, Toptal, and Palantir.
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