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In 2016 the Medical Device Single Audit Program (MDSAP) was initiated. Having a global approach to monitoring and ...
A concept similar to the FDA’s Design History Files, the EU Technical File is a collection of documents related to ...
Cosmetics are a separate category under the Food and Drug Administration (FDA) different from medical devices or ...
A quality management system, QMS, is a crucial requirement for any organization in the life sciences ...
Aseptic technique is the practice and procedures utilized to prevent contamination from pathogens. There are four ...
The approval of new and generic drugs and biologics requires compliance with the Food and Drug Administration ...
Whenever risk is identified whether it is part of a process or the design of a product, mitigation of the risk ...
It has been a wild past two years trying to figure out what products can mitigate, treat, diagnose or even cure ...
Since 2016, the 21st Century Cures Act (Cures Act) has been implemented to expedite medical product development ...
Many microbes are harmless to humans, but some can cause serious health problems. Microbes can spoil food, ...
Post-market surveillance is necessary for ensuring compliance as regulatory bodies have the authority to impose ...
Submitting a 510k for a medical device can be a long and confusing process. When a 510k is submitted the device ...
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