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Explore the essential design controls for medical devices, a regulatory framework vital for ensuring device safety, traceability, and consistent quality. Arterex Medical outlines key phases—from planning and defining user needs to verification, validation, design reviews, change control, and maintaining a Design History File (DHF). These structured controls are required by FDA’s 21 CFR 820.30 and align with ISO 13485 standards. Design controls provide a formal structure to link user needs to design inputs and outputs, ensuring that every requirement is met and thoroughly tested.
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