As of August 2021, the 510(k) submission for the FreeStyle Libre 2 IOS App Glucose Monitoring System designed by...
Testing
Corrosion and Characterization Methods
Corrosion is a chemical process by which metal, stone, or other materials are broken down via the formation of oxides,...
Trends In 2020 FDA Pharma Warning Letters
The recent trend of U.S. Food and Drug Association citations issued to those operating in the pharmaceutical...
Non-Destructive Testing Methods
Non-destructive testing methods are critical in characterizing the properties and features of any material or product...
Western Lifestyle Increases COVID-19 Severity
Researchers in the United States have developed an experimental infection model of the Syrian hamsters that were fed a...
Stability Testing of Pharmaceuticals and Supplements
Whether you are working on a prescription drug, over-the-counter (OTC) drug, or even a dietary supplement, stability...
Considerations for Biocompatibility Evaluation
Biocompatibility is one of the most critical performance studies that manufacturers need to perform as part of their...
Stability Testing Requirements for Pharmaceuticals
Deciding how and when to conduct stability tests on your new drug can be challenging. Stability tests provide evidence...
Developing a Med Device Traceability Matrix
If you have developed a medical device, you know how important the concept of traceability is. Every facet of the...
Medical Device Biocompatibility
If your medical device has contact with human tissue, it is a safe bet that you will be required to conduct...
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