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 […]
China issues new procedures for medical device registration
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 MassDevice.com or its […]
How EU MDR and human factors affect design user-friendly software user interfaces
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 […]
MDR delay impact extends beyond European Union
By Timothy Herr, Emergo Group While we have reported on the one-year delay of Europe’s Medical Devices Regulation (MDR) due to the COVID-19 pandemic, we have not yet touched on the ramifications that this decision has on countries outside the European Union. The United Kingdom and the nations of the European Free Trade Association (EFTA) […]
IMDRF recommends UL 2900 compliance for medical device cybersecurity
By Stewart Eisenhart, Emergo Group Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
Eudamed updates phased implementation for European medical device, IVD database
By Ronald Boumans, Emergo Group The implementation of the European Database for Medical Devices, Eudamed, has been delayed by two years and the implementation of the Medical Devices Regulation (MDR) has been delayed by one year. The European Commission has informed Emergo that parts of Eudamed will be made available to users before the official […]
Control Medical wins 510(k) for blood clot removal device
Control Medical Technology (Park City, Utah) announced today that the FDA has cleared its Aspire MAX 7 – 11F mechanical thrombectomy device to remove blood clots from peripheral vessels. Peripheral thrombectomy is associated with peripheral arterial disease (PAD), acute limb ischemia (ALI), critical limb ischemia (CLI), chronic total occlusion (CTO), deep vein thrombosis (DVT), pulmonary […]
Roche Diagnostics win FDA EUA for COVID-19 antibody test
Roche Diagnostics has received FDA emergency use authorization (EUA) for its Elecsys Anti-SARS-CoV-2 COVID-19 antibody test. The test will identify antibodies to determine if a person has ever been infected with the coronavirus. The presence of SARS-CoV-2 antibodies in human serum or plasma can also indicate an adaptive immune response. Switzerland-based Roche has begun shipping […]
DeviceTalks Weekly: Ep. 8 – AdvaMed‘s Scott Whitaker on pandemic readiness, Jon Norris of SVB shares Q1 VC data
In this week’s episode of DeviceTalks Weekly, Scott Whitaker, CEO and president of AdvaMed, shares concerns he had over how the federal government would work with the medtech industry during the pandemic crisis. Does he feel the medtech industry was treated fairly? How does he see the federal government and medtech industry working together in […]
How ISO 14971 will affect usability engineering
By Richard Featherstone, Emergo Group The third edition of international standard ISO 14971 (Medical devices—application of risk management to medical devices) is now available. This third version, dated December 2019, cancels and replaces the second edition (ISO 14971:2007). There are a number of changes, some of which relate directly to usability. ISO 14971:2019 is recognized […]
DeviceTalks Weekly: Ep.7 – Edwards, employment news, update on clinical trials from Avania
In this week’s episode of DeviceTalks Weekly, Tom Salemi and Chris Newmarker stare at each other through the Zoom lens while talking about the positive employment news from Baxter International and Conformis, the hopeful news from Edwards Lifesciences, and the cautionary tone from Medtronic. What can we expect from the rest of medtech? In the […]
