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The FDA defines validation as a process required to establish documented evidence that provides a high ...
Claims are defined statements, symbols, or wording that are made on a product. They can be advertising, ...
Providing a quality product while meeting all quality standards set by regulatory bodies can often prove to be a ...
With the implementation of the new Medical Device Regulation (MDR) 2017/745 in the European Union, a ...
In the United States, medical devices are regulated by the FDA. In the European Union, medical devices ...
Medical devices have advanced beyond the point of simple machinery. Software has begun playing an ...
A fundamental question in any drug development program is which regulatory pathway to pursue. There are ...
Suppliers play a pivotal role in life sciences companies. Whether they are providing a company with ...
Process Validation is a formal methodology that companies utilize to manufacture products with a ...
The FDA regulates a wide range of manufactured goods for consumers, including food, electronics, ...
Every organization that manufactures medical devices, pharmaceuticals, biologics, cosmetics, or other ...
Navigating ever-changing markets and supply chains has been challenging for many companies in the ...
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