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la82 replied to the topic Making up tests for design verification and validation in the forum Introduction to Design Controls 8 years, 5 months ago
Hello Roberto,
I have done some research like my classmates, it was interesting to read that the FDA points out to verification not only in terms of tests. They list guidelines such as analysis and inspections. I agree with my classmates that they don’t have a specific list, but they provide major explanation and overall explanation of how to conduct the verification activities in their design control guidance. The link attached has the complete guide specific for medical devices, and it explains in details all the needed information to conduct a successful verification process.
http://www.fda.gov/downloads/MedicalDevices/…/ucm070642.pdf
– Lamiaa