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The FDA has numerous methods of enforcing its regulations, known as enforcement actions. There are 4 total main ...
A remote audit is a way of conducting an audit without being physically present. The overall goal is to evaluate ...
CBD oil is now a part of many consumers' lives, through lifestyle products, food supplements, and even cosmetics. ...
One of the main strategies to eliminate cervical cancer is the consistent screening of people with cervixes. ...
As people are becoming increasingly concerned with the Earth’s future, they are looking for more sustainably ...
All things must inevitably come to an end, including a medical device recall. Whether voluntary or FDA mandated, ...
There is an innate benefit to utilizing statistical techniques in any manufacturing process, but even more so for ...
Engaging in medical device product development requires establishing and documenting design controls. The FDA ...
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The new EU MDR 2017/745 is complex, to say the least. Depending on a company’s relationship to the medical device ...
When making a new product, whether that product is a drug, a medical device, or a combination product, ...
When an error occurs, corrective and preventative actions are developed to help strengthen the quality ...
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