Resources

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 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. Emergo by UL can assist you in obtaining CE Marking so you can sell your medical device in any of these European countries.

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 exploring these publications.

Medical Device Registration - Mexico Updates

In this complimentary webinar, we will examine current medical device registration requirements in Mexico and recent regulatory changes.

Post-Market Clinical Follow-up (PMCF) Studies Under the EU MDR

In this white paper, learn about PMCF studies in the context of the change from the current Medical Devices Directive 93/42/EU (MDD) to the new Medical Devices Regulation (MDR 2017/745/EU).

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EU IVDR Readiness Assessment Checklist

This brief checklist will help you to determine how to bring your in vitro diagnostic medical device company into compliance with the EU IVDR.

Designing Safe and Effective Instructional Materials for Medical Devices

Learn useful tips and gain a greater understanding of how to evaluate or design instructional materials for your medical devices and systems.

Resources

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Medical Device Testing Requirements for 510(k) Submissions

IVD Medical Device Clinical Performance Evaluation Studies

European Countries that Require CE Marking