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srg36 replied to the topic Why VERIFICATION is important? and Your ideas to improve Verification process ? in the forum Introduction to Design Controls 7 years, 9 months ago
Just to add to what was mentioned by several people, they mentioned doing design verification early and often. However, design verification cannot be performed until the design is frozen, which does not happen early in a project. However, you can do characterization at any time throughout the design process to assess the design to make sure you are on the right track, and I would highly recommend doing this. I think one thing that could characterize a “poor verification practice” is having design inputs that are not realistic, and that do not challenge the device. Defining accurate, robust design inputs is absolutely critical to ensure the device will be safe to patients. A device that passed verification testing with flying colors does not necessarily mean it is a safe product, because it all depends on what the acceptance criteria was.