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 […]
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) […]
Insulet resumes next-gen Omnipod pivotal study following software issues
Insulet (NSDQ:PODD) today said it has resumed its pivotal study of its next-generation Omnipod Insulin Management System after pausing the study in March due to a software anomaly. The company paused the study about halfway through completion to correct an issue that could result in the system using an incorrect glucose value that had the potential to impact […]
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 […]
Icon appoints new chief medical officer
Icon said it appointed Kristen Buck as chief medical officer. Prior to joining the company, Buck was senior VP and chief of clinical development at Optum Insights where she led the clinical operations and regulatory group. She has experience in multiple therapy areas, including GI, neuroscience, dermatology, ophthalmology, oncology, cardiovascular/metabolic, immunology, renal, women’s health, orphan […]
Kindeva Drug Delivery launches as independent company from 3M
Kindeva Drug Delivery recently announced that it launched as an independent company, shedding its former 3M Drug Delivery Systems name. The formation of the independent company follows its acquisition by Altaris Capital Partners in a transaction that was worth $650 million. Through the acquisition, 3M will hold a 17% minority interest in Kindeva with Altaris. […]
Tandem Diabetes Care posts wider-than-forecast losses in Q1
Tandem Diabetes Care (NSDQ:TNDM) posted first-quarter results that beat the revenue consensus on Wall Street but missed on earnings. The San Diego-based company — maker of insulin pumps and other diabetes management devices — reported losses of -$14.9 million, or -25¢ per share, on sales of $97.9 million for the three months ended March 31, for […]
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 […]
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