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COVID-19 resources, news, and analysis
Visit our new resource center to stay informed about global medical device news related to COVID-19.
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New EU Technical File Builder designed for MDR compliance
A fast, efficient system to create medical device technical documentation compliant with MDR 2017/745
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MDR Gap Assessment and CE Transition Strategy
Europe's new Medical Devices Regulation 2017/745 (MDR) is finally here and takes effect in mid-2020.
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More companies apply early-use testing
Manufacturers can use testing to save time, money, and effort during product development
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MDR resource center checklist
MDR Resource Center

The knowledge you need for MDR implementation

Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. Meet our MDR team and get free educational resources on the MDR.
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India’s CDSCO responds to COVID-19 with new approval, import, and safety measures

A series of notices outline policies designed to promote efficient outbreak response and safeguard employee...
Has FDA relaxed its human factors expectations in response to the COVID-19 pandemic?

Meeting FDA requirements for human factors engineering and usability during the COVID-19 emergency

European Commission officially proposes one-year MDR delay

European regulators officially propose delaying Medical Devices Regulation date of application in order to deal...
BARDA opens research portal to combat COVID-19 pandemic

The US government body is seeking input from stakeholders about products and technologies that could...

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MDR Transition: Countdown to compliance
Webinar
Market Access
MDR Resource Center
MDR Transition: Countdown to compliance

Thu Apr 09

Applying usability to medical device design presentation featured at MEDI’NOV Connection 2020
Workshop
Human Factors Research & Design
Applying usability to medical device design presentation featured at MEDI’NOV Connection 2020

Tue Jun 23

News

Get the latest global medical device regulatory news, insights from our experts, and more. View All

Emergo by UL’s 510(k) Builder for more efficient FDA premarket submissions now live on RAMS software platform

Emergo by UL has launched 510(k) Builder, a new software tool supporting streamlined generation of...
Emergo by UL experts present on human factors engineering in healthcare robotics

Members of the HFR&D team appeared at the inaugural Healthcare Robotics Engineering Forum in Santa...

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