Emergo by UL resources

Introduction to Human Factors Engineering

Understand how HFE's user-centered design process supports the development of safer medical devices.

Human Factors Engineering for Medical Technology

This certificate's series of eight courses provides a professional with a solid working knowledge of human factors engineering for medical devices.

Medical Device Regulatory Requirements - New Japanese Guidelines

In this complimentary webinar, we review the resources you’ll require and the steps you should take to complete your path to market in Japan.

Writing User Interface Requirements

Join the HFE experts at Emergo by UL as they discuss both tips to follow and pitfalls to avoid when writing user interface requirements.

Medical professional using electronic controls to test a medical scanning device.

Design and Evaluation of Electronic Instructions for Use (eIFUs)

Join the HFE experts at Emergo by UL as they discuss regulator expectations for electronic instructions for use (eIFUs).

Technician operating diagnostic equipment for a patient.

New Medical Device Usability Engineering Standard from MHLW

The new JIS T62366-1:2022 standard comes with updated requirements on usability engineering for medical devices.

2022 Outlook – Updates for Europe’s Regulatory Landscape: Recent Changes in the EU, United Kingdom and Switzerland

Watch this webinar to learn the anticipated updates to the EU IVDR 2017/746 and EU MDR 2017/745, what to look out for from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the next steps for Switzerland.

2022 Outlook and Updates for the US Food and Drug Administration

Review recently released and expected guidance documents from the US FDA, the growing use of real-world evidence and regulatory science tools in submissions, and expectations for 2022 and beyond.

Performance Evaluation – When, What and How to Prepare for EU IVDR

This webinar explains the Performance Evaluation concept introduced by IVDR 2017/746 and focuses on the interaction of elements required for manufacturers to perform an adequate Performance Evaluation.

MDR Update: Common Themes from Medical Device Manufacturers

In this complimentary webinar, we examine resources developed by the European Commission.

Phone with app being used for blood glucose monitoring.

Software as a Medical Device (SaMD): EU/US Regulatory Considerations

In this webinar, we provide information on considerations for designing and classifying SaMD in the United States and European Union.

Office supplies over drawing of risk mapping.

Scaling and Conducting Use-Related Risk Analysis (URRA)

Watch the HFE experts at Emergo by UL as they discuss the importance of conducting URRAs effectively.

Senior man using blood pressure cuff in his home

Bringing Medical Devices Home

Watch as HFE experts discuss the application of HF engineering to medical devices intended for at-home use.

Medical Device Registration – Brazil ANVISA

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

6 Key Principles of GDPR

General principles of GDPR and actions manufacturers can take to gain or maintain compliance.

HIPAA Regulations

Secure data management to meet HIPAA, PHI, and requirements of Covered Entities or Business Associates.

HIPAA & GDPR Overview

Secure data management to meet HIPAA, GDPR requirements and achieve regulatory compliance.

EU MDR Readiness Assessment Checklist

Use this short checklist to assess what your medical device company needs to do to comply with the EU MDR.

Taiwan TFDA Regulatory Approval Process for Medical Devices & IVDs

Taiwanese TFDA Regulatory Approval Process for Medical and IVD Devices

This process chart illustrates the TFDA approval process per device classification in Taiwan and is available for download in the Regulatory Affairs Management Suite (RAMS).

Indian Regulatory Approval Process for Medical and IVD Devices

This process chart illustrates the CDSCO approval process per device classification in India and is available for download in the Regulatory Affairs Management Suite (RAMS).

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.

Introduction to Human Factors Engineering

Human Factors Engineering for Medical Technology