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. […]

By Stewart Eisenhart, Emergo Group Brazil’s medical device regulator ANVISA is nearing implementation of a new “notification” market pathway 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 DrugDeliveryBusiness.com or its employees.

By Allison Strochlic, Emergo Group I just had a baby – my second daughter. This means that, like over 98% of my fellow American moms-to-be, I checked into a local hospital to have nurses and doctors oversee what I hoped would be the smooth delivery of my baby. This entitled me to the firsthand experience […]

By Stewart Eisenhart, Emergo Group India’s Central Drugs Standard Control Organization (CDSCO) continues expanding oversight to more types of medical devices, now planning to require registration for eight additional device types starting April 1, 2020. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]