Hardware Podcasts

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

Global Medical Device Podcast · 13 May 2020 · 45m · Episode 146

What this episode covers

Host John Spear of Greenlight Guru interviews Devon Campbell, founder of Prodct LLC, and Anthony Habayeb, co-founder and CEO of Monitaur.ai, about the challenges and frameworks for integrating artificial intelligence (AI) and machine learning (ML) into medical devices. The discussion centers on 'Machine Learning Assurance,' a process for auditing and monitoring ML models to ensure safety and effectiveness in regulated environments, contrasting it with traditional Quality Management Systems (QMS). The guests share insights from FDA workshops and guidance, emphasizing the need for a 'culture of quality control' and Algorithmic Change Protocols (ACP) to manage the risks of evolving algorithms in Software as a Medical Device (SaMD).

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru, Prodct LLC, Monitaur.ai, FDA, Butterfly Network

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