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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 ...
The three-year transition period to the EU MDR does not only engage the Regulatory Affairs personnel in Medical ...
The government has temporarily “re-opened” until Feb 15th after the longest government shutdown in US history that ...
The field of mobile medical applications (apps), software that run on smartphones or other mobile communication ...
The new EU MDR is set to go into effect in May 2020. The transition to the new regulations is burdensome for some ...
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