Resources

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

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

Lab tech putting away a binder on a shelf

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.

Person working at a laptop while checking a clipboard.

How the IVDR Impacts Intended Purpose and Classification

In this webinar, our Emergo by UL expert outlines the latest updates on how the IVDR impacts intended purpose and classification.

Stethoscope laying on a printed bar graph

Clinical Data in Support of U.S. FDA 510(k) Submissions

Read this white paper to learn about FDA requirements for clinical evidence.

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Software as a Medical Device (SaMD) (Presented in French)

Regardez maintenant : le logiciel en tant que dispositif médical (SaMD) : considérations réglementaires UE/USA

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Preparing for IVDR Certification

In this webinar, our Emergo by UL subject matter expert outlines the latest updates about preparing for IVDR certification regulation updates.

Implementation of EU EUDAMED

Learn about EUDAMED database compliance requirements for medical device and in-vitro diagnostics (IVD) companies in Europe.

EU Market Regulations Update – How to Manage Expiring Notified Body Certificates

In this webinar, our Emergo by UL subject matter expert outlines the latest EU market regulatory updates.

Making the Most of Your Investment in Human Factors

Gain a deeper understanding of how investment can yield dividends in enhancing a product’s interactive qualities.

Graphic depicting correct and incorrect ways of wearing a mask

Designing Effective Quick Reference Guides

Watch our webinar to learn how to design safer, more usable and appealing quick reference guides for medical devices and systems.

Doctor standing over patient in a hospital

Usability Testing of Medical Technology

Usability testing gives the gift of user feedback, which subsequently can help you design a better product. Learn how to uncover flaws across different portions of the user interface, make changes to correct the flaws and mitigate risk.

Residual Risk Analysis of User Interaction Problems

Residual risk analysis generates the insights and supporting data necessary to decide if a product is a “go” for launch.

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Threshold Analyses

In this white paper, we discuss assessing user interface design differences between approved and proposed combination products and medical devices.

Conceptual Design of a Product’s User Interface

A comprehensive conceptual design effort is likely to place your user interface design process on the right path, avoid ill-advised shortcuts and help ensure that the final product is safe, effective, and satisfying to use.

Applying Human Factors to Wearable Medical Devices

Wearable medical devices form a close, sometimes intimate relationship with the wearer. This makes wearable medical devices a prime target for human factors specialists’ research, design, and evaluation efforts.

Combination Products: Common Use Errors and Design Considerations

Manufacturers have a responsibility to predict likely use errors and, wherever possible, to “design out” the error such that the user automatically uses the product as intended to reduce use-related harm.

myTSF™ adult and pediatric home screen design

Breathing life into a new use experience vision: The Smith+Nephew myTSF™ Mobile App

Learn how our Human Factors Research & Design team helped the Smith+Nephew myTSF™ Mobile App with user interface design, formative usability testing and HF validation testing.

Overview of New Brazilian Regulation RDC 751/2022

In this Emergo by UL webinar, our subject matter expert outlines the latest updates to the new Brazil regulation.

Revita® DMR (duodenal mucosal resurfacing) System close up procedure

Fractyl: Revita® DMR (duodenal mucosal resurfacing) System

Discover how our HFR&D experts supported Fractyl on various topics, including the formative and HF validation test strategy of their product (Revita® DMR [duodenal mucosal resurfacing] System).

Nuubo®: The Nuubo System

Uncover how our HFR&D experts helped a small startup with no experience in HFE regulations bring a non-invasive, remote electrocardiograph (EDG) to market.