MedTech Compliance & Risk Consulting

Our expertise

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US FDA Medical Device Establishment Registration and FURLS Listing

FDA Establishment Registration

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China Medical Device Registration and Approval

Emergo by UL's experienced consultants can provide insight on how to navigate the evolving regulatory landscape in China and guide you through China NMPA approval and registration for medical devices.

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European Post-market Clinical Follow-up Studies (PMCF) for Medical Devices

Our clinical consulting team can help you clearly define the objective of your post-market clinical study, design the study, create a protocol, implement the study and analyze the data.

European Authorized Representative for Clinical Trials

Emergo by UL can act as your authorized representative (legal representative) for medical device and IVD clinical trials and performance trials in Europe.

Latest MedTech news

The latest industry insights from our global team.

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Sep 21, 2023

UI Design Trends for Healthcare and Medical Apps

Good user interface (UI) design ensures that users have a valuable and enjoyable experience when interacting with an application. For mobile apps related to healthcare, a UI that prioritizes the user is of utmost importance as these applications are developed with the goal of improving patients’ lives and the level of care they receive.

Man trying an at-home blood pressure device

Sep 21, 2023

Out-of-the-Box Usability Testing for Medical Devices | Emergo by UL

Human factors specialists might opt to conduct an “out of the box” usability test of a medical device, such as for a home-use blood pressure monitor. In any case, it’s a great way to assess the user experience from the very start of product interactions.

multiple analysts conducting a usability study

Sep 20, 2023

Conducting Usability Tests with Multiple Analysts | Emergo by UL

Overcome challenges associated with conducting human factors usability tests with multiple analysts by practicing effective notetaking and data collection.

Sep 18, 2023

Details on Declaration Route for Class I Medical Devices in Israel

As Emergo by UL reported in August, the Ministry of Health in Israel, Medical Device Division, AMAR, announced (August 14, 2023) proposed amendments to the medical device regulatory system.

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MedTech

US FDA Medical Device Establishment Registration and FURLS Listing

China Medical Device Registration and Approval

European Post-market Clinical Follow-up Studies (PMCF) for Medical Devices

European Authorized Representative for Clinical Trials

UI Design Trends for Healthcare and Medical Apps

Out-of-the-Box Usability Testing for Medical Devices | Emergo by UL

Conducting Usability Tests with Multiple Analysts | Emergo by UL

Details on Declaration Route for Class I Medical Devices in Israel

European In Vitro Diagnostic Devices Regulation (IVDR) CE Marking Regulatory Process

Comprehensive Guide to FDA Clearance for Your Medical and IVD Device

Japanese Regulatory Approval Process for Medical Devices

Australian TGA Regulatory Approval Process for Medical and IVD Devices

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Thank you! We've received your request.

MedTech

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US FDA Medical Device Establishment Registration and FURLS Listing

China Medical Device Registration and Approval

European Post-market Clinical Follow-up Studies (PMCF) for Medical Devices

European Authorized Representative for Clinical Trials

UI Design Trends for Healthcare and Medical Apps

Out-of-the-Box Usability Testing for Medical Devices | Emergo by UL

Conducting Usability Tests with Multiple Analysts | Emergo by UL

Details on Declaration Route for Class I Medical Devices in Israel

Filter by

European In Vitro Diagnostic Devices Regulation (IVDR) CE Marking Regulatory Process

Comprehensive Guide to FDA Clearance for Your Medical and IVD Device

Japanese Regulatory Approval Process for Medical Devices

Australian TGA Regulatory Approval Process for Medical and IVD Devices

Request information from our specialists

Thank you! We've received your request.