This article delves into the critical importance of design control in the creation of medical devices. Through a comprehensive exploration, we highlight how design control plays a pivotal role in guaranteeing patient safety and ensuring the effectiveness of these devices.
Design control is a critical process in the development of medical devices that ensures patient safety and product efficacy. It involves a systematic approach to managing the design and development of these devices, from conception to commercialization. This process includes defining design inputs, conducting risk assessments, creating design outputs, and verifying and validating the product.
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