Mastering SaMD: Navigating Regulations & The Product Lifecycle

Upcoming Virtual Courses

Expert Insights

Mastering SaMD: Navigating Regulations & The Product Lifecycle (Sep 2024)

Sep 17 to Sep 19, 2024


SaMD (Software as a Medical Device) is one of the fastest growing types of Medical Devices in the world. This is creating a unique situation where traditional software companies are now becoming Medical Device Manufactures (MDMs) and traditional MDMs are developing more and more software.

This training is designed to give attendees a crash course in software only medical devices. Learn and understand what software qualifies as SaMD and how it can be unique from commercial software as well as from traditional medical devices. The webinar will provide a high-level review of the Quality Management System Regulations (QMSR) from a software lens. Learn what portions of the QMSR apply to SaMD and what that means for your company.

This training will also provide an overview of all the software activities required by ANSI/AAMI/IEC 62304:2006/A1:2016 and the FDA’s General Principles of Software Validation (GPSV). This will include Safety & Security Risk Management, Software Development & Implementation, Software Verification, Design Validation, Software Releases & Maintenance, and other various required activities for SaMD.

Lastly, this training will guide you from both angles to support you in becoming a SaMD expert. Register now and accelerate your journey to better understand the regulations, development, implementation, and validation of SaMD


Over the course of (6) hours, the attendee will:

  • Understand what SaMD is and how it is unique
  • Understand how to utilize industry standard software development practices to meet the compliance requirements of medical device software
  • Understand how Medical Device Regulations specifically apply to software only devices

Who Should Attend?

Anyone wanting to better understand medical device software regulations or software only medical devices.

  • Software Engineers and Managers
  • Other R&D Engineers and Managers
  • Quality Engineers and Managers
  • Regulatory Specialists

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


David Nelson

Associate Software Director, Boston Scientific Neuromodulation

David has a background in Software Engineering and has 26+ years of experience developing and validating Medical Devices. He currently is an Associate Software Director for Boston Scientific Neuromodulation.  His responsibilities include managing all aspects of software development and validation including security risk.  In addition, David is a faculty member at AAMI and has been developing and instructing courses for more than 12 years.