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What is FDA QSR? Differences between FDA QSR and ISO 13485
In the realm of medical device manufacturing, compliance with regulatory standards is paramount. Two key frameworks governing quality management are the Food and Drug Administration Quality System Regulation (FDA QSR) and the International Organization for Standardization (ISO) 13485. While both aim to ensure product safety and quality, they differ in scope, certification processes, and global […]
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What is FDA 483? Important Details About FDA 483 Forms
The FDA 483 form plays a crucial role in safeguarding consumer health by ensuring that products manufactured and circulated in the US market meet strict quality and safety standards. In this article, GOL will provide you with important information about the FDA 483 form, including its contents, issuance process, response methods, and consequences of non-compliance. […]
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What is ultra-processed food? How does it affect health?
In today’s modern food landscape, the term “ultra-processed food” has become increasingly prevalent, sparking discussions and debates about its impact on health. As we navigate through aisles lined with brightly colored packaging and seemingly endless options, it’s crucial to understand what exactly constitutes ultra-processed food and the implications it holds for our well-being. From convenience […]
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The process of registering medical devices with the FDA
The process of registering medical devices with the FDA is a crucial step for companies looking to bring their products to market in the United States. With a healthcare landscape governed by stringent regulations and evolving standards, understanding and successfully navigating the FDA registration process is essential for ensuring compliance and facilitating market access. From […]