There is a lot of hype around artificial intelligence (AI) and machine learning (ML) these days. That is why Michael Bocchinfuso encourages Quality/Regulatory professionals in this episode to go beyond the hype and understand these rapidly emerging technologies at a deeper level.
These rapidly evolving technologies offer unique opportunities in the medical device space. To succeed, QA/RA professionals should clearly articulate and emphasize the clinical benefit, anticipate regulatory questions about model bias, and carefully consider risks arising from the use environment.
His advice is to collaborate and facilitate an informed conversation across different functions to help optimize for both safety and effectiveness.
About Michael Bocchinfuso
Michael Bocchinfuso is currently the Director of Regulatory Compliance and Quality at Koios Medical. He is an electrical and software engineer by training. Early in his engineering career, he worked in avionics designing PCBs, and testing and improving reliability of these systems. He then moved into a Quality Engineer role in the medical device industry helping to ensure high quality standards and compliance during product development and beyond. In his current role, he closely collaborates with the product development teams working on AI/ML enabled medical devices in radiology applications, while maintaining an effective and compliant QMS, and coordinating regulatory activities related to various submissions in different countries across the world.
About Let’s Talk Risk! with Dr. Naveen Agarwal
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
Ep 19: How QA/RA professionals can help drive innovation in AI/ML