Software as a Medical Device (SaMD): The Lifecycle of Quality

Summary

Are you interested in learning more about creating safe and effective software products to improve patient care? This online course experience provides an introduction to FDA regulations for SaMD (software as a medical device). From the beginning stages of project planning to post-deployment software monitoring, this course will outline the basic expectations and FDA requirements. Perfect for regulatory newbies and veterans alike, this course breaks down complex SaMD regulations into manageable, straightforward, and engaging lessons.

Learning Objectives

After completing the program, learners will be able to:

• Identify the key phases of SaMD product development and post-deployment monitoring
• Recognize basic regulatory terminology
• Describe the importance of patient safety and patient risk as it relates to SaMD product development

Upon successful completion of the program, learners earn a certificate of completion.

This online self-paced course contains 60-90 minutes of videos, helpful visuals, easy-to-understand explanations, and engaging activities related to SaMD software products.

Topics covered include:

• Assumptions Before Starting
• Regulatory Determination
• Project Planning
• Quality Management Systems
• Design Planning
• Design Inputs and Outputs
• Verification and Validation
• Transfer Activities
• Design Transfer
• Post-Deployment Software Monitoring

Click here to view the course overview.

This course is designed for anyone wanting to learn more about translating software as a medical device (SaMD), including AI, into clinical practice.

	David E. Vidal, J.D. Vice Chair, SaMD Regulatory David is an attorney and FDA quality/regulatory expert focused on SaMD. As Vice Chair of Regulatory in Mayo Clinic's Center for Digital Health, he is leading the development of enterprise-wide infrastructure to enable safe, effective, and ethical realization of FDA regulated software.
	Mark A. Lifson, Ph.D. Director, AI Systems Engineering Mark has guided system design and software algorithm releases for CE marking medical devices, led novel R&D product development efforts, managed clinical trials/research studies, and authored numerous scientific articles and patents.
	Brenna T. Loufek, M.S. SaMD Regulatory Affairs Manager Brenna has extensive experience providing regulatory strategies to development teams for software-based products, including AI/ML-based technologies, telehealth platforms, and in-clinic management tools.
	Megan G. Graham, M.S. SaMD Quality Assurance Manager Megan has over 25 years in the medical device industry, where she held roles in Research & Development, Quality, Regulatory, and Operations. She has led multiple enterprise initiatives focused on developing organizational competencies and practices. Megan has a passion for improving quality, reliability, usability, safety, security, and privacy in the medical device industry.
	Ashwani Khurana, Ph.D. SaMD Clinical Investigation Manager Ashwani has been working in clinical research and regulatory affairs for more than four years. He has held several roles focused on drug, device, Biologics approval, post approval changes and product life cycle management in Cardinal Health and Mayo Clinic. Most recently, he managed SaMD products, drafted global CMC strategy for drugs/services and risk assessment.
	Joe Melnick AI Systems Engineer Manager Joe is an engineering professional with over 17 years of experience in the medical device industry seeking to advance and implement industry leading methods for Mayo product development. His work in the field has led to the launch of cardiac ablation, ophthalmic, infectious disease and hematology IVD, and consumer wearable medical device products.
	Bryce F. Flor Principal AI Systems Engineer Bryce is an avid practitioner of model-based systems engineering methodologies and spent several years working on large-scale, complex products in the aerospace, defense, and medical device industries. More recently, Bryce has stood up digital, collaborative engineering environments and toolchains to enable streamlined product development from conception, design & development, launch, and sustaining operations.
	Stephanie C. Bernthal, M.S.Ed. AI Curriculum Developer Stephanie has vast experience initiating, researching, creating, and delivering training experiences on a variety of education-related topics. She has extensive experience in both in-person and virtual training environments. She has a passion for creating training experiences that are both fun and engaging, regardless of the topic.