Coronavirus (COVID-19) Update: FDA publicly shares antibody test performance data from kits as part of validation study
These results are among the first to come from a collaborative effort by the FDA, NIH, Centers for…
05 Jun 20
These results are among the first to come from a collaborative effort by the FDA, NIH, Centers for…
The MDR changes will enforce stricter rules on clinical evaluation processes, safety, classification and performance of medical device…
Experts on ventilator regulation in the US and UK weigh in on what relevant bodies have done to…
Manufacturers from industries including automotive want to help the UK ventilator shortage during the Covid-19 crisis - but…
05 Mar 20
The agency said that the ESDs are causing unreasonable risk of illness or injury, which cannot be corrected…
Medical device failures can have adverse consequences for healthcare professionals, as well as patients, in certain cases
14 Feb 20
There is increasing pressure on the FDA to give members of the public improved access to details of…
As the UK prepares to leave the EU at 11pm GMT today, the medical device sector looks set…
The medical device tax has been suspended since 2016 - but is one step away from being repealed…
The WannaCry ransomware attack in 2017 highlighted the need for the NHS and the medical device companies it…