Taking a more rigorous approach to investigating fatal medical errors in the U.S.

Emergo GroupBy 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 of the accident.

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 employees.

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Australia medical device regulators prepare Brexit contingency plans

Emergo GroupBy 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 those of MassDevice.com or its employees.

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Italian medical device nomenclature to be used for Eudamed database

Emergo GroupBy 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 blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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U.S., Canadian regulators warn potential medical device shortages after Sterigenics shutdown

Emergo GroupBy 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 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 employees.

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Brazil ANVISA launches notification pathway for low-risk medical devices and IVDs

Emergo GroupBy 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 MassDevice.com or its employees.

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Safeguarding against no-shows and late participation in medical device usability testing

Emergo GroupBy 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. Another 5 minutes goes by – 1:35PM – maybe your participant got stuck in traffic or is having difficulty finding a parking spot. You call and ask your recruiters if they’ve heard from the participant recently. At 1:45PM, your recruiters call back and tell you that the participant is sick and won’t be able to participate as scheduled. Now what?

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 employees.

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Brazil to implement ANVISA Class I medical device notification pathway

Emergo GroupBy 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 MassDevice.com or its employees.

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India CDSCO adds new medical devices to regulated list

Emergo GroupBy 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 only and do not necessarily reflect those of MassDevice.com or its employees.

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FDA final guidance on safety and performance 510(k) medical device registration

Emergo GroupBy 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.

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 employees.

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How diary studies can support medical device human factors engineering and usability

Emergo GroupBy 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 method that involves participants self-reporting data over an extended time period. Participants can record data in physical pen and paper diaries, or using one of many digital platforms that offer added value and efficiency.

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 employees.

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