Coronavirus (COVID-19) Update: FDA publicly shares antibody test performance data from kits as part of validation study

By NS Medical Staff Writer

05 Jun 20

These results are among the first to come from a collaborative effort by the FDA, NIH, Centers for…

RegulationRegulatory Policy

EU confirms Medical Devices Regulation is postponed until 2021

By Dan Robinson

20 Apr 20

The MDR changes will enforce stricter rules on clinical evaluation processes, safety, classification and performance of medical device…

RegulationRegulatory Policy

Have US and UK medical device regulators done all they can to ease ventilator shortages caused by Covid-19?

By Jamie Bell

15 Apr 20

Experts on ventilator regulation in the US and UK weigh in on what relevant bodies have done to…

RegulationApprovals

The regulations non-medical manufacturers may need to overcome to tackle ventilator shortages

By Jamie Bell

27 Mar 20

Manufacturers from industries including automotive want to help the UK ventilator shortage during the Covid-19 crisis - but…

RegulationApprovals

FDA bans ESDs intended for self-injurious or aggressive behaviour

By NS Medical Staff Writer

05 Mar 20

The agency said that the ESDs are causing unreasonable risk of illness or injury, which cannot be corrected…

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Seven serious medical device malfunctions that have led to urgent FDA recalls

By Jamie Bell

04 Mar 20

Medical device failures can have adverse consequences for healthcare professionals, as well as patients, in certain cases

RegulationRecalls

Why the FDA needs to be more transparent when it comes to reporting medical device failures

ByEmma Green, Medical Device Developments

14 Feb 20

There is increasing pressure on the FDA to give members of the public improved access to details of…

RegulationRecalls

Stricter rules following Brexit will hurt the UK medical devices industry, says analyst

By Jamie Bell

31 Jan 20

As the UK prepares to leave the EU at 11pm GMT today, the medical device sector looks set…

RegulationRegulatory Policy

What is the medical device tax and why is it on the verge of being permanently scrapped in the US?

By Jamie Bell

20 Dec 19

The medical device tax has been suspended since 2016 - but is one step away from being repealed…

RegulationRegulatory Policy

Are medical device companies doing enough to protect their technologies against cyber-attacks?

By Jamie Bell

10 Dec 19

The WannaCry ransomware attack in 2017 highlighted the need for the NHS and the medical device companies it…

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