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Description:
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Learn how to turn user needs into clear, beginner-friendly test plans for Software as a Medical Device (SaMD). In this episode, we break down the essentials of SaMD validation—no PhD required! We cover:
- Why testing matters: Real-world examples of what can go wrong (and how to avoid it)
- From user needs to test cases: Simple “if-then” steps you can try today
- Who should test: Pros and cons of in-house vs. external testers
- eQMS basics: How to validate your electronic Quality Management System with minimal hassle
- Quick tips: The one thing you must do first, and the top beginner pitfall to avoid
Whether you’re a developer, QA engineer, or healthcare innovator, you’ll walk away with practical strategies to ensure your medical software is safe, reliable, and compliant. Tune in and make your next SaMD project a success!
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The post Software as a Medical Device: Beginner’s Guide to Testing & Validation appeared first on Medical Device made Easy Podcast. hamza benafqir |