Global Software as a Medical Device (SaMD) Training Suite
Master the regulatory landscape and development lifecycle of Software as a Medical Device (SaMD) with Leap Compliance’s comprehensive eLearning suite. Designed for busy professionals—including software engineers, QA specialists, and regulatory affairs teams—these engaging micro-topics provide the essential insights you need to build safe, effective, and compliant medical device software.
Flexible, Self-Paced Learning
This is a fully self-paced program, meaning you can book and begin your training at any time. You have complete control over your learning journey: choose to complete the comprehensive 8-module bundle for a robust overview, or select individual modules to focus on specific topics like Cybersecurity, AI/ML, or Risk Management.
What You Will Learn
The training suite is divided into 8 targeted micro-modules:
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Module 1: Introduction to SaMD and Global Regulations
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Module 2: IEC 62304 - Building Safe and Reliable Medical Device Software
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Module 3: IEC 62304 - Software Design and Setting Your Requirements
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Module 4: Risk Management and Usability (Human Factors)
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Module 5: Cybersecurity and Data Privacy
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Module 6: Software Testing: Verification and Validation
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Module 7: SaMD Maintenance
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Module 8: AI/ML SaMD - Extra Considerations