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

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

In this episode, Anindya Mookerjea will share with us his knowledge on Software Testing. We will review the basics and help you with being compliant to your projects. The post Software as a Medical Device: Beginner’s Guide to Testing & Validation appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device made Easy Podcast

June 12, 2025

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Show Notes

miniature episode 340 Software as a Medical Device: Beginner’s Guide to Testing & Validation  monir el azzouzi easy medical device  Anindya Mookerjea

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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episode 340 Software as a Medical Device: Beginner’s Guide to Testing & Validation monir el azzouzi easy medical device Anindya Mookerjea

The post Software as a Medical Device: Beginner’s Guide to Testing & Validation appeared first on Medical Device made Easy Podcast. hamza benafqir

Topics

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