Software as a Medical Device: Beginner’s Guide to Testing & Validation

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! 

• Anindya Mookerjea:  https://www.linkedin.com/in/anindyamookerjea 
• S-Cube Technologies: https://eqms-smarteye.com/ 

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

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