Technical Training

Introduction to SaMD and Global Regulations - On Demand e-Learning

Introduction to SaMD and Global Regulations

Looking to start your learning in the world of SaMD without committing to lengthy training? This on-demand microlearning course is your ideal starting point. In just 60 minutes, you'll gain foundational knowledge of global SaMD regulations, classifications, and market access strategies—critical for anyone involved in the development, testing, or commercialisation of SaMD.

This course is available on demand so that you can learn about SaMD at a date and time that suits you. If you have any questions please connect with our team.

Learning Objectives

Upon completion of this course, learners will be able to:

• Understand device classification for SaMD devices according to the FDA and EU regulatory frameworks
• Identify other regulatory frameworks for the IMDRF countries
• Understand the different routes to market for SaMD devices
• Select the appropriate regulatory strategy for a given SaMD device
• Understand when and why to apply ISO 13485 and Identify gaps in your current compliance systems

Course Content

• What is SaMD?
• Global regulatory landscape of SaMD: Identify and differentiate between regulation, standards, and guidance
• Regulatory requirements (standards, legislation and guidance)
• Understanding device classification
• Mobile Medical Applications
• Activity: classify your SaMD
• Regulatory Pathways in the EU and USA
• Regulatory requirements (standards, legislation and guidance)
• An introduction to risk including examples of applying IEC 62304 and ISO 14971
• Activity: Develop a route to market
• QMS and ISO 13485 for SaMD
• Test your knowledge

Who should attend

The course is suitable for professionals involved in the development, testing, and commercialization of SaMD, including regulatory professionals, software engineers, designers, Quality Engineers, IT support, R&D engineers, and clinicians.

Upcoming dates: