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The International Medical Device Regulators Forum released updates from its working groups on good regulatory review practices, unique device identifier harmonization, adverse event terminology and standards. Read More
The International Medical Device Regulators Forum released updates on regulatory works in progress in member countries following its March 20-22 IMDRF meeting in Shanghai. Read More
The International Medical Device Regulators Forum released new consultation documents on personalized medical devices and on optimizing standards for regulatory use following its March meeting in Shanghai. Read More
China’s Food and Drug Administration reported that International Medical Device Regulators Forum (IMDRF) members unanimously supported China’s proposal for a new work item on clinical evaluation of medical devices — presented during the March 20-22 IMDRF meeting in Shanghai. Read More
With a multitude of sensors, wearables and mobile devices becoming available for use in clinical trials, sponsors should conduct systematic comparisons before designing protocols, according to experts at the annual SCOPE conference, who presented the work they’ve done to demonstrate the value of using digital monitoring in their studies, as well as the obstacles they encountered. Read More
Cyberattacks on medical imaging devices such as CT and MRI devices are poised to become a major challenge for device manufacturers, according to researchers at Ben Gurion University of the Negev, Israel. Read More
Member medical device companies at four of the top industry trade associations worldwide have made a major change in how they support healthcare professionals’ education and training. Read More
The FDA flagged two overseas facilities for inadequate medical device reporting and improper handling of nonconforming products, and cited a Florida devicemaker for numerous issues observed in a July inspection. Read More
3D printing is poised to transform the medical device industry, according to several players in the space who participated in a recent FDAnews webinar. Read More
An inspection in March by the FDA of ELITech Group’s facility in Spankeren, The Netherlands prompted a warning letter after the device manufacturer failed to follow through with the promises made in response to a Form 483 report. Read More
The International Medical Device Regulators Forum released final guidance that lays out procedures for sharing confidential postmarket surveillance for medical devices among regulators. Read More