Quality Control and Process Validation in Medical Device Manufacturing
DOI:
https://doi.org/10.70445/gjus.2.2.2025.105-129Keywords:
Quality Control, Process Validation, Medical devices, Regulatory Compliance, FDA guidelines, Manufacturing Processes, Quality AssuranceAbstract
Medical device manufacturers must incorporate quality control and process validation as a part of the process, which guarantees the safety of the product, its reliability, and regulatory compliance. Quality control aims at identifying defects by inspection and testing and process validation comes up with documented evidence that the manufacturing processes continuously produce devices within specifications that have been defined. Collectively, they create a system of quality that is integrated and reduces the risks and improves the consistency of products. This review identifies regulatory frameworks, methodologies, tools, challenges, and new trends of these practices. As the complexity of devices increases, and global regulations become stricter, implementing new technologies and lifecycle-oriented approach is essential to continue upholding high-quality standards and enhancing patient safety outcomes.
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