Currently browsing "Design Controls"
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Verification vs Validation in QMS: Key Differences for Compliance
Quality Management Systems (QMS) in regulated industries, such as pharmaceuticals, biotechnology, and medical devices, rely on two critical yet frequently misunderstood processes: verification and validation. These concepts form the foundational pillars of robust QMS frameworks, ensuring that products are both built correctly and fit for their intended use. When organizations misinterpret or misuse these terms, […]
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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 […]
