By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration addresses premarket authorization requirements for multiple-function products with at least one function that qualifies as a medical device. 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 […]
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Eudamed completes actors module testing
By Ronald Boumans, Emergo Group On April 12, 2018, 20 representatives of stakeholders from industry and European Competent Authorities (CAs) had the opportunity to test the first Eudamed module. This module will be used for entering actor data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Health Canada launching new unit for digital health technology licensing
By Stewart Eisenhart, Emergo Group Medical device regulators at Health Canada are developing a more targeted oversight approach for digital health technologies such as mobile medical applications. 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 […]
What Brexit withdrawal means for MDR implementation in the U.K.
By Ronald Boumans, Emergo Group Negotiators discussing how the UK will leave the European Union have reached a draft Withdrawal Agreement about the transition period. The transition will start on March 29, 2019 and will end on December 31, 2020. Instead of 12 months from now, there are 21 months to prepare. This is still […]
HFES conference to host workshop on risk analysis for summative usability tests
By Kate Jablonski, Emergo Group A workshop session at the 2018 International Symposium on Human Factors and Ergonomics in Health Care will provide insights into conducting residual risk analyses for summative usability tests for medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
China CFDA proposes regulatory framework for 3D-printed medical devices
By Stewart Eisenhart, Emergo Group Medical device market regulators at the China Food and Drug Administration (CFDA) have published new guidance proposing registration requirements for devices produced via 3D printing or additive manufacturing. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
Brain implant for some blind people shows benefits of FDA’s Breakthrough Device Program
Malvina Eydelman, M.D., Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation FDA’s Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act to help patients gain timely access to breakthrough technologies. Consider Second Sight […]
MDSAP certification expanded for Brazilian, South American medical device companies
By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has officially extended applicability of the Medical Device Single Audit Program (MDSAP) to domestic manufacturers as well as other companies based in South America. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
Indian CDSCO releases FAQ on medical device rules
By Stewart Eisenhart, Emergo Group The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, has published a new Frequently Asked Questions (FAQ) document to clarify industry questions regarding the country’s new medical device oversight system. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
FDA plans 2018 update for global UDI database
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration will soon implement updates to its Global Unique Device Identification Database, or GUDID, based on feedback and requests from medical device manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]