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On April 2, 2019, FDA released their proposed regulatory framework for modification to Artificial Intelligence / ...
Does a Human Factors/Usability Engineering (HFE) validation study need to be completed for your medical ...
Randomized controlled trials have long been the gold standard for collecting clinical data on investigational ...
With the initial Brexit plans derailed and the deadline now being extended to April 12th, the trade and ...
Does your medical device Risk Management process include Usability / Human Factors Engineering (HFE)?
For many ...
3D printing has a multitude of applications in the medical device field. Right from the inception of the additive ...
For medical devices, ISO (International Organization for Standardization) is one of the most significant ...
It is likely that you know someone who has received a ligament or tendon replacement, a cornea transplant, or a ...
Outstanding innovations come with the heavy burden of dealing with new risks and threats. Especially when public ...
With the mounting tensions that the new EU MDR has put on medical device manufacturers, the ripple effects can be ...
With the new EU MDR, companies must comply with several new requirements. Our previous blogs gave a snapshot of ...
In December 2018, the U.S. Food and Drug Administration formally recognized a public database that contains ...
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