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Continuously growing elements of the Industry 4.0 are the bits and bytes, or data. With platforms like Internet of ...
It is no secret that brand-name drugs in America are often expensive. Luckily, for the many American’s who are not ...
Now more than ever, the Emergency Use Authorization (EUA) pathway for medical devices has become a popular topic. ...
The US FDA’s Center for Devices and Radiological Health (CDRH) announced a new pilot program that will allow the ...
In this webinar, we will be covering what exactly an SaMDs, or Software as a Medical Device, and go over some ...
In this second part of the webinar, we will review how to tackle changes that were made to the software post ...
This webinar will explore the Medical Device Single Audit Program, or MDSAP. We will provide an overview of the ...
One of the paradigms of the next generation computing tools is Augmented Reality (AR) where animated objects are ...
Few people outside of the industry know how big of a role the FDA has in product labeling and packaging. Every ...
The De Novo pathway establishes new classification categories for novel low-to-moderate risk devices, which in ...
Imagine a platform where innovations meet modern healthcare services while following regulatory requirements. Such ...
FDA recently released a proposed rule that amends its existing regulations around establishing the intended use of ...
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