FDA announces plan to resume on-site inspections in the US this month
The FDA is monitoring Covid-19 cases and hospitalisations across the US to determine places which will be safe…
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16 Jul 20
The FDA is monitoring Covid-19 cases and hospitalisations across the US to determine places which will be safe…
Trade association MedTech Europe is 'raising the alarm' over the implementation of new EU IVD regulations, which are…
Claiming temperature screening products can reliably detect Covid-19 could put people’s health at risk, according to the MHRA's…
24 Jun 20
The intent is to reduce transmission of SARS-CoV-2 by those with documented or suspected infection by replacing CPAP…
The Department of Defense has agreed to fund Covid-19-related production projects following an agreement with the US Development…
18 Jun 20
Agency continues effort to help protect public health from fraudulent products
05 Jun 20
Small sponsor companies depend heavily on outsourcing their clinical trial activities due to limited resources, specific knowledge and/or…
05 Jun 20
These results are among the first to come from a collaborative effort by the FDA, NIH, Centers for…
03 Jun 20
The new EU MDR has been delayed until May 2021 due to the Covid-19 crisis, but it still…
The MDR changes will enforce stricter rules on clinical evaluation processes, safety, classification and performance of medical device…