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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 ...
With the fast approaching Brexit date, the possibilities of Britain exiting the EU without striking a deal are very
In September 2013, FDA published a final rule establishing a Unique Device Identification (UDI) system to identify ...
On January 7th, FDA released a working model for the software pre-certification pilot program version 1.0. The ...
In contrast to 2014, news on the Ebola virus today is relatively minimal. However, Ebola outbreaks are still ...
On December 22nd, 2018, the Federal Government went into a partial shutdown. Forty one percent of the FDA staff has
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