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A 510(k) is a premarket submission made to the Food and Drug Administration (FDA) by medical device manufacturers ...
Whether looking to update an existing process or implement something brand new, process design is a critical ...
Since its inception, EMMA International has been dedicated to providing consulting services to help ensure ...
Accurate and precise measurements are vital in the pharmaceutical, medical device, and other FDA regulated ...
Many controls are well-designed and put in place to help drive and maintain the quality of the sterile drugs ...
How does a medical device manufacturer make sure that they prevent garbage from coming into their factory, and ...
The European Commission has implemented a proposal to extend the transitional period to certify medical devices ...
After over 3 years, the COVID-19 Public Health Emergency (PHE) will end on May 11, 2023, the Biden Administration ...
All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set ...
Depending on the factory, some production employees may find it surprising that management has an important role ...
In addition to helping manufacturers make better products, corrective and preventive actions are important because ...
All of life entails some about of risk. The most humans can really do is mitigate the destructive effects of these ...
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