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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 ...
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 ...
FDA is not the only organization that can review 510(k) submissions. Under the Third Party (“3P”) Review Program, ...
We witnessed several changes in the medical device industry in the year 2018. The impact of some changes was ...
Medical Device manufacturers selling their devices in the European Union are currently in a three-year transition ...
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