By Stewart Eisenhart, Emergo Group Significant revisions to Japanese regulations of medical devices, IVDs and other healthcare products have begun taking effect, with phased implementations (link in Japanese) of new and updated requirements planned through 2022. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]

By Dietmar Falke, Emergo Group The European Medical Devices Regulation (MDR) demands that “confirmation of conformity with relevant general safety and performance requirements under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk-ratio, shall be based on clinical data providing […]

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time. Get the full story here at the Emergo Group’s blog. The opinions expressed […]

By Timothy Herr, Emergo Group China’s Center for Medical Device Evaluation (CMDE) issued two announcements recently outlining revised procedures relating to medical device registration. 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 those of DrugDeliveryBusiness.com or its […]

By Kimmy Ansems and Linda Giesselink, Emergo Group Emergo by UL’s Human Factors Research and Design team has extensive experience developing software user interfaces and instructional materials for various medical devices. In the fourth blog post in our series on the European Medical Devices Regulation (MDR) and human factors engineering, we reference various MDR General […]