The COVID-19 pandemic has had a broad and prevalent impact on the FDA and “normal” medical device life as the ...
In Europe, medical devices are regulated under the Directive 93/42/EEC—the “Medical Devices Directive” (MDD) which ...
Just like every other nation, Australia has also taken several measures to respond to the global pandemic. To help ...
The COVID-19 pandemic has caused mass shortages of ventilators and PPE globally, but now healthcare workers are ...
In our last blog on COVID-19’s impact on the EU MDR, the commission had not yet laid out any intentions of moving ...
Canada has been facing the same difficulties as many other nations due to the novel coronavirus. In light of the ...
Are you a manufacturer and want to help with the COVID-19 Pandemic? We invite you to attend our upcoming webinar ...
Health care facilities are facing shortages of medical equipment, drugs, PPEs and essentials such as hand ...
In 2012, the International Medical Device Regulators Forum (IMDRF) developed the Medical Device Single Audit ...
Amid the pandemic situation, and states’ officials struggling to secure Personal Protective Equipment, FDA ...
On Tuesday, March 31, 2020, the FDA announced a new program aimed at facilitating research and development of ...
Our Lead Quality Engineer, Nikita Angane, explains how to build a strong Quality Management System for your ...