ニュース

European Union flags flying in front of a building

2020年6月9日

The European MDR and Human Factors Engineering: Designing User-friendly Software User Interfaces

Emergo by UL’s Human Factors Research and Design team has extensive experience developing software user interfaces and instructional materials for various medical devices.

2020年6月8日

"Rushing Slowly" to Market: Applying Human Factors to Fast-tracked Medical Products

Keeping human factors engineering and usability considerations front and center when seeking expedited emergency market access for medical devices and technologies.

2020年5月29日

Latest Insights on FDA Expectations from the 2020 Virtual HFES Health Care Symposium

FDA recognizes the constraints that COVID-19 has placed on in-person testing, but emphasized the importance of seeking

2020年5月13日

Handling Incidental Findings in Human Factors Research

In the course of research, the chance exists of encountering results unrelated to your study that potentially impact the lives of participants. How should you respond to such events, and how can you and your team prepare for them?

2020年4月28日

Implications of the New ISO 14971 Edition for Usability Engineering

The new version of the international standard features increased emphasis on several areas that will require the attention of medical device manufacturers.

2020年4月20日

The European MDR and Human Factors Engineering: Use-related Risks

As with the European Medical Devices Directive (MDD), the MDR expects usability engineering to be incorporated into the overall risk management and device development process.

2020年4月15日

Exploring the Business Benefits of Inclusive Design

Designing medical devices to be accessible to users with special needs has an ethical appeal, but it also can be good for your company's bottom line.

Person at a desk with laptop and monitor.

2020年3月26日

Continuing to make progress on human factors work during the COVID-19 pandemic

Tips and recommendations for how to continue critical HFE and usability studies for medical devices while maintaining social distancing and remote work. Learn more at Emergo by UL's Human Factors Research & Design unit.

2020年3月25日

The European MDR and Human Factors Engineering: Intended Purpose

In the second blog post in our series on human factors engineering and the European Medical Devices Regulation (MDR), we will discuss intended purpose:

2020年3月4日

The European MDR and Human Factors Engineering: Introduction

Emergo by UL's Human Factors Research & Design (HFR&D) experts examine how Europe's MDR affects HFE and usability requirements for medical device manufacturers.

2020年2月17日

Human Factors Terminology Breakdown

When learning about new areas of work, understanding the important terms and their relation to one another is a great start. Medical device human factors and design fields are no different.

2020年2月10日

Japanese Regulatory Ministry Publishes Guidance on Biocompatibility Testing to Updated Standard

The Ministry of health, labour and welfare (MHLW) has published notification No. 0106-1, requiring manufacturers to test in accordance with JIS T 0993-1:2020.

次の条件で絞り込み

The European MDR and Human Factors Engineering: Designing User-friendly Software User Interfaces

"Rushing Slowly" to Market: Applying Human Factors to Fast-tracked Medical Products

Latest Insights on FDA Expectations from the 2020 Virtual HFES Health Care Symposium

Handling Incidental Findings in Human Factors Research

Implications of the New ISO 14971 Edition for Usability Engineering

The European MDR and Human Factors Engineering: Use-related Risks

Exploring the Business Benefits of Inclusive Design

Continuing to make progress on human factors work during the COVID-19 pandemic

The European MDR and Human Factors Engineering: Intended Purpose

The European MDR and Human Factors Engineering: Introduction

Human Factors Terminology Breakdown

Japanese Regulatory Ministry Publishes Guidance on Biocompatibility Testing to Updated Standard

弊社専門スタッフにお問い合わせください。

ありがとうございました。

ニュース

次の条件で絞り込み Loading...

次の条件で絞り込み

The European MDR and Human Factors Engineering: Designing User-friendly Software User Interfaces

"Rushing Slowly" to Market: Applying Human Factors to Fast-tracked Medical Products

Latest Insights on FDA Expectations from the 2020 Virtual HFES Health Care Symposium

Handling Incidental Findings in Human Factors Research

Implications of the New ISO 14971 Edition for Usability Engineering

The European MDR and Human Factors Engineering: Use-related Risks

Exploring the Business Benefits of Inclusive Design

Continuing to make progress on human factors work during the COVID-19 pandemic

The European MDR and Human Factors Engineering: Intended Purpose

The European MDR and Human Factors Engineering: Introduction

Human Factors Terminology Breakdown

Japanese Regulatory Ministry Publishes Guidance on Biocompatibility Testing to Updated Standard

弊社専門スタッフにお問い合わせください。

ありがとうございました。