Currently browsing "Design Controls"
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The Importance of the Design History File in Medical Device Development
How does one ensure that every phase of medical device development is meticulously documented and compliant with regulatory standards? The answer lies in effectively managing the Design History File (DHF). This critical document serves as a comprehensive record that tracks the design process of a medical device, from conception through to market release. It plays […]
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Mastering Design Controls: A Guide for Medical Device Manufacturers
The global medical devices market is on a sharp upward trajectory, projected to expand by 5.70% annually and reach a staggering value of US$638 billion by 2028. This rapid growth amplifies the need for rigorous design controls to ensure products are innovative, safe, and effective. With the high stakes, the pressure on manufacturers to adhere […]
