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 […]
Safeguarding against no-shows and late participation in medical device usability testing
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. […]
Brazil to implement ANVISA Class I medical device notification pathway
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.
When human factor specialists become the patient
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 […]
India CDSCO adds new medical devices to regulated list
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 […]
Senseonics wins MRI-safe FDA nod for Eversense CGM
Senseonics announced that it has received notice from the FDA that its Eversense sensor no longer has to be removed for MRI scanning. “Based on our testing, we have demonstrated hat it is safe for patients to leave the Eversense Sensor in place, even when they need to have an MRI,” Tim Goodnow, president and […]
FDA final guidance on safety and performance 510(k) medical device registration
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s medical device oversight division has rolled out final guidance on an expanded 510(k) registration route retooled to focus on device safety and performance issues, and is seeking industry comment on proposed changes to its predicate device policy. The opinions expressed in this blog post […]
How diary studies can support medical device human factors engineering and usability
By Erin Davis and Benjamin Basseches, Emergo Group Some people might assume that diaries are only used to record the day-to-day trials and musings of teenagers. But – surprise! – diaries (specifically, diary studies) are actually a valuable method to add to your ethnographic research toolkit. Generally speaking, a diary study is a qualitative research […]
European MDR designates first notified body
By Ronald Boumans, Emergo Group The new Medical Devices Regulation (EU) 2017/745 is not an update of the current Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/382/EEC (AIMDD); it requires all devices to be certified again. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
Latest Brexit agreement voted down by British Parliament
By Ronald Boumans, Emergo Group On January 15th, 2019, the UK Parliament voted the Brexit agreement down by a record majority of 432 against 202. The Brexit agreement was the result of negotiations between the EU and the UK negotiators. Previously it had been accepted by EU leaders and the UK government, but required approval […]