Software as a Medical Device: Beginner’s Guide to Testing & Validation
Description
■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!
► Links from the Video
■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:
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice
United States
