By Stewart Eisenhart, Emergo Group Following Emergo by UL’s recent webinar on the European Union’s General Data Protection Regulation (GDPR) and human factors studies for medical devices, we examine key GDPR compliance issues human factors researchers must address to avoid steep penalties. The webinar was presented by Allison Strochlic and Alexandria Trombley, Research Director and […]

By Stewart Eisenhart, Emergo Group US medical device regulators are planning more focused evaluations of materials used in the manufacture of medical devices for safety issues. 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 […]

By Stephanie Larson and Richard Featherstone, Emergo Group Nicotine replacement therapy (NRT) drug products, such as patches, gum and lozenges, have been around for more than 30 years. More novel products such as e-cigarettes provide additional choices for people using NRT for smoking cessation. But, like any other drug delivery mechanism, there are risks as […]

By Ronald Boumans, Emergo Group The United Kingdom (UK) may leave the European Union (EU) on 29 March 2019. The draft agreement on Brexit has not yet been ratified by the UK and the EU parliaments. The Netherlands and the EU are therefore still preparing for various scenarios. One of those scenarios is that no […]

By Stewart Eisenhart, Emergo Group On Friday, March 1, 2019, a Tesla automobile was involved in a fatal crash in Palm Beach, Florida. Considering the possibility that the vehicle crash occurred while the vehicle was in autopilot mode, the National Highway Traffic Safety Administration (NHTSA) and the National Transportation Safety Board (NTSB) initiated an investigation […]

By Stewart Eisenhart, Emergo Group The Australian Therapeutic Goods Administration (TGA) has developed measures to minimize potential negative market impacts of the UK’s Brexit withdrawal from the European Union. 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 […]

By Ronald Boumans and Stewart Eisenhart, Emergo Group Authorities overseeing implementation of the European Database for Medical Devices (Eudamed) have decided to adapt medical device codes used by the Italian Ministry of Health for use as nomenclature for the database. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]

By Stewart Eisenhart, Emergo Group Medical device regulators in the US and Canada are both investigating whether the recent shuttering of a sterilization facility in Illinois due to environmental concerns may impact supplies of devices, and have provided recommendations for affected manufacturers in need of new sterilization sites. Get the full story here at the […]

By Stewart Eisenhart, Emergo Group Brazil’s medical device regulator ANVISA has issued a new regulation for a “notification” market pathway providing streamlined market access for low-risk devices. 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 […]

By Rachel Aronchick, Emergo Group It’s 1:25PM, and you’ve just jotted down “P6” – the 1:30PM participant’s unique identifier – at the top of your moderator’s checklist in preparation for your next test session. Five minutes go by, and it’s time for the scheduled session – surely they’ll walk in the door any second now. […]