By Stewart Eisenhart, Emergo Group Part three of our blog series on common medical device quality system audit problems examines ways to deal with difficult auditees in order to successfully obtain information and evaluate processes. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
SystemOne announces 4 new countries using GxAlert for diagnostic data
SystemOne, a connected diagnostics company developing data-driven healthcare insight and solutions, has announced 4 new GxAlert implementations in Africa and the Middle East. SystemOne develops software and networking solutions to move and make use of data from diagnostic instruments focused on infectious disease. SystemOne users receive over 20,000 instant alerts from diagnostic devices each month […]
European Parliament approves new medical device, IVD regulations
By Stewart Eisenhart, Emergo Group The European Parliament has officially voted to approve the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR), allowing implementation efforts for these major new regulations to proceed. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
Medtech stories we missed this week: April 7, 2017
New studies for umbilical cord allografts and tumor targeting were published this week while another company received European CE Marking. Here are some medtech stories we missed this week but thought were still worth mentioning. 1. AMNIOX touts new umbilical cord study AMNIOX Medical announced that it has published the results of 3 studies that demonstrate […]
MFDS launches new medical device recall system in South Korea
By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) has rolled out a new system for medical devices subject to recalls in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
Saudi Food and Drug Authority plans changes for medical device marketing application
By Stewart Eisenhart, Emergo Group Saudi Arabia’s medical device regulator, the Saudi Food and Drug Authority (SFDA), plans to introduce changes to the application process for obtaining market authorization in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]
Singapore changes medical device field safety notice requirements
By Stewart Eisenhart, Emergo Group Singapore’s medical device market regulator now requires registrants issuing field safety notices (FSNs) regarding their products to copy managers of affected local healthcare facilities. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
This contact lenses breakthrough could enable glucose monitoring
Biosensing contact lenses may not be able to self-heal like “The Terminator,” but they could measure blood glucose and detect other signs of disease in the future. Oregon State University researchers are set to present a study that suggests transparent biosensors that are embedded into contact lenses could provide insight for doctors and patients without […]
Russian technical file requirements for medical devices and IVDs clarified by regulators
By Stewart Eisenhart, Emergo Group The Russian Ministry of Health has issued a new regulation to explain longstanding but unofficial technical file and instructions for use requirements for medical device and IVD registrants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
Philips sees image-guided therapy transforming healthcare: Here’s how
Officials at medtech giant Royal Philips see image-guided therapy as key when it comes to health practitioners providing care that is both efficient and effective. The Dutch multinational’s work in the field provides a great example of how the ever-growing need for cost-effective healthcare around the world is driving the strategies of medical device companies. […]