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!

Link

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

Social Media to follow

• 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

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