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ROI CalculatorDesign Control is the structured process to plan, document, review, verify, validate, and approve product design to ensure it meets user needs and regulatory requirements.
For medical devices, FDA 21 CFR 820.30 requires documented design planning, design inputs and outputs, design reviews, verification, validation, design transfer, and design changes. ISO 13485 mirrors these requirements as part of its design and development controls.
Why it matters: weak design control is a common cause of recalls, safety issues, and major inspection findings.
