Machine Learning for Medical Devices

Upcoming Virtual Courses

Expert Insights

Machine Learning for Medical Devices (May 2024)

May 30 to May 30, 2024


With the rise in Big Data and increased horsepower of computing platforms, there is a surge in the development of Machine Learning-based Medical Devices (MLMD.) As with any new technology, there are many benefits, risks, and challenges in the safe and effective development and adoption of MLMD. This training provides an overview of the technology, discusses what is different between MLMD and traditional software development, and reviews the regulatory and standards landscape – both domestic and international -- for MLMD. 

As with any new technology, there are new challenges regarding the safety and efficacy of Machine Learning when used in medical devices.  This course will highlight those differences and will provide a snapshot of the current standards and regulatory landscape on machine learning for medical devices.


Over the course of two (2) hours, the attendee’s will:

  • Be able to understand the differences between traditional software development and software development for Machine Learning systems.
  • Be able to understand the current standards landscape for ML systems (both inside and outside of healthcare), including an overview of the AAMI/BSI TIR 34971 regarding risk management for ML systems, and also a proposed process for bias management.
  • Be able to understand the current regulatory landscape for ML systems, including the FDA, EU, China’s NMPA, and efforts underway with the IMDRF.

Who Should Attend?

Software Development Managers, Quality Managers, and Regulatory Affairs Professionals.

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email


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Pat Baird, MBA, MS

Head of Global Software Standards, Phillips

2011 Standards Developer Award, AAMI
Co-chair or convenor of several AI Committees (AAMI, ISO/IEC SC42, CTA, WHO, MITA, MDIC)