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

How have manufacturers adapted to demands of the EU Medical Device Regulation as coronavirus brings more firms to the sector?

ByProfessor Herman Pieterse

26 Mar 20

The legislation's purpose is to bring similar safety controls and transparency to medical device products as to those…

DevicesRegulationCertifications

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…

DevicesRegulationRegulatory Policy

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The medical device tax has been suspended since 2016 - but is one step away from being repealed…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

RegulationCertifications

FDA warns about risk of unapproved stem cell therapy

By NS Medical Staff Writer

04 Sep 19

The FDA's recent inspection revealed that the Stemell was manufacturing products derived from human umbilical cord blood and…

DevicesRegulationRegulatory Policy

NextFlex’s Technology Hub complies with FDA Standards for manufacturing of medical devices

By NS Medical Staff Writer

09 Aug 19

Adherence to FDA quality standards will boost ability of fabrication facility to produce pilot-scale devices for NextFlex members…

RegulationRegulatory Policy