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On Monday, the FDA provided an update on its software precertification program known commonly as the Pre-Cert ...
We are deeply saddened by the loss of such a great legal icon and scholar. Justice Ruth Bader Ginsburg, or the ...
Hundreds of medical devices have been placed on the US market under an Emergency Use Authorization (EUA) to aid in ...
Drug facility pre-approval inspections are required to grant a complete response letter from the FDA to get a new ...
The Application Programmable Interface or the API is the modern data access tool for developers. It acts like ...
Computational Intelligence (CI) is one of the major pillars of Artificial Intelligence. It is the study, design, ...
The long-awaited Brexit is set to take place on December 31st, 2020. This is when Britain will exit the European ...
It may seem straightforward to determine if a product is a medical device or not but there is a surprising amount ...
The COVID-19 pandemic is still creating headlines in the health care domain. Around the world, governments, and ...
For the most part, everyone in the medical device industry is familiar with the term “510(k)”, but not many people ...
FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) released a ...
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC -- AIMD) and the Medical Devices ...
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