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sjm39 replied to the topic Making up tests for design verification and validation in the forum Introduction to Design Controls 8 years, 4 months ago
As my classmates have mentioned the FDA does not demand specific tests for design verification or design validation. The FDA ensures good quality assurance practices with the 21 CFR Part 820.30 that Dr.Simon mentioned in his lecture. This regulation does not describe the practices that must be used but establishes the framework that manufacturers must use when developing and implementing design controls. The framework gives manufacturers the guidance and flexibility to design tests that fit their unique product while also meeting the regulations.