Emergo by UL resources

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Developing Effective Training to Enhance and Support Internal HFE Resources

Learn about principles for developing training and resources to support the effective application of human factors engineering (HFE) to medical product development.

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Conducting Usability Tests in China for NMPA: An Overview of Considerations Based on Past Learnings

Learn how the NMPA’s HFE guidelines impact HFE work and the best ways to plan and conduct usability tests in China for NMPA.

PMS & PSUR Requirements Under the EU MDR

This whitepaper presents the new MDR requirements regarding PMS obligations and the risks resulting from their implementation in a global QMS.

Understanding Europe's New Medical Device Regulation - MDR 2017/745

In this white paper, take a look at MDR 2017/745 and how it will impact medical device manufacturers.

Brexit at Work: Placing Medical Devices and IVDs on the UK Market

This white paper references the EU-UK Trade Agreement signed in December 2020 and the available guidance documents to provide a roadmap for marketing medical devices and IVDs in the UK post-Brexit.

Human Factors Engineering for Medical Devices

Twenty years after FDA first called upon manufacturers to apply human factors engineering (HFE) in medical device development, HFE has become a relatively mainstream activity.

MHRA - UK Medicines and Healthcare Products Regulatory Agency

MHRA overview. Read more about UK’s medicines and healthcare products regulatory agency and see the most important medical device regulations

Mexico – Overview of Medical Device Industry and Healthcare Statistics

You will find basic demographic and healthcare market data on Mexico, plus specific information about the medical device and healthcare industries.

Applying Human Factors and Usability Engineering to Medical Devices (GERMAN) - Part I

Emergo by UL offers a wide range of services to medical device developers, including human factors engineering and design services.

Meeting FDA Expectations for Human Factors Engineering Activities

FDA has provided industry with guidance on how to apply human factors engineering (HFE) to the development of medical technology.

An Intensive Look at Methods for Identifying Potential Use Errors

To support safe and effective use of medical device and combination products, it is incumbent upon manufacturers to identify and mitigate use-related risks during product development.

COFEPRIS - Mexico Ministry of Health

Read more about Mexico's federal committee for protection from sanitary risks and see the most important medical device regulations

Medical Device Testing Requirements for 510(k) Submissions

In this white paper, we'll show you how to navigate FDA databases testing standards and guidances related to your device.

IVD Medical Devices Clinical Performance Evaluation Studies

IVD Medical Device Clinical Performance Evaluation Studies

In Europe, certain in vitro diagnostic (IVD) devices must undergo clinical performance (CP) evaluation studies conducted in accordance with current regulations in order to obtain CE Marking.

European Countries that Require CE Marking

The European Union comprises 28 countries that require CE Marking.

Taiwan TFDA Regulatory Approval Process for Medical Devices & IVDs

TFDA - Taiwan Food and Drug Administration

Within the Ministry of Health and Welfare, the Taiwan Food and Drug Administration (TFDA) was established in 2010 to oversee food, drug, and medical device safety and quality.

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2021 Medical Device Industry Outlook

Read the results of our 2021 Medical Device Industry Outlook Survey, based on responses from 1600 professionals.

ANVISA - Brazil National Health Surveillance Agency

The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical

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RAMS Top FAQs

Get answers about registering, renewing accounts and what tools you’ll find in RAMS.

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Human Factors Research & Design Publications

Gain deep insights into Human Factors Engineering (HFE) and its applications to medical device design by reading these publications.

Resources

All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.