Resources

Early Communication with the FDA

Learn more about tips and other information to help you feel comfortable when corresponding with the FDA.

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Clarifying the Complexity of Human Factor Engineering

Expectations among regulatory bodies are growing just as HFE methods become more and more complex. How will you meet the requirements involved with marketing a medical device?

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2023 South Korea Regulatory Overview

In this webinar, our Emergo by UL subject matter expert outlines the latest updates on medical device regulatory requirements in South Korea.

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Knowledge Task Testing to Validate Instructions and Warnings

Learn about the FDA’s expectations for knowledge tasks and how to plan for and conduct knowledge tasks during usability testing.

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Japan Regulatory Requirements – PMDA Pre-submission Consultation Program

In this webinar, our Emergo by UL expert outlines the latest updates on regulatory requirements in Japan.

Performance Evaluation – When, What and How to Prepare for EU IVDR (Presented in Portuguese)

Este webinar explica o conceito de Avaliação de Desempenho apresentado pelo IVDR 2017/746 e aspectos fundamentais a considerar para seu produto.

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5 Tips to Ease Nervous Participants During Product Evaluations

Learn how to improve feedback and reduce the nervousness in participants during medical device user research studies.

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Global Regulatory Compliance for Medical Devices

Learn more about taking a strategic approach to achieve regulatory approval in medical device markets around the world.

Meeting Global Regulations and Expectations for HFE

Meet the human factors engineering (HFE) expectations, regulations and standards of a global marketplace.

US FDA electronic Submission Template and Resource (eSTAR)

Watch our Emergo by UL subject matter expert as they outline the latest updates about US FDA electronic Submission Template and Resource (eSTAR).

MDR: Common Issues for Medical Device Manufacturers (Presented in Portuguese)

This presentation, presented in Portuguese, reviews the resources of the European Commission.

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Applying Human Factors in the Course of Post-Market Surveillance

Develop a greater understanding of the importance of incorporating human factors engineering (HFE) into post-market surveillance activities.