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Prepare efficient FDA 510(k) submissions with RAMS
The RAMS 510(k) Builder allows you to create your submission with guided form completion software, collaborate with teammates, and format your document to FDA requirements.
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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

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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A leading consultancy with more than 2,800 medical device and IVD clients worldwide.

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Emergo's CRO team is 100% focused on clinical research for medical devices.

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Meet regulator expectations and reduce your risk of cyber threats with early cybersecurity assessments.

Blog

The latest industry news and insights from our global team. View All

MDR Watch: New Joint Implementation plan as multiple challenges to Regulation compliance arise

European MDCG Joint Implementation plan for MDR ahead of May 26, 2020 compliance deadline

US FDA publishes new guidance documents and issues ESD ban

510(k) clearance help and a therapeutic use of one device type deemed too risky
Hong Kong regulator will continue to recognize South Korean approvals

The MDD's trial on the feasibility of leveraging MFDS authorization has been extended until the...
US FDA postpones foreign medical device inspections due to COVID-19 concerns

Alternative device and quality management system inspection methods to be used until postponement is lifted

Events

Learn from our experts through live webinars, workshops, and tradeshows. View All

ISO 14971:2019 and the current state of risk management
Webinar
Market Access
ISO 14971:2019 and the current state of risk management

Thu Mar 26

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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