뉴스 | Emergo by UL

Person pulling a test strip out of a machine

2020년8월6일

Understanding Customers and Their Needs in Human Factors Engineering

Figuring out what users hope to get out of a medical device or IVD requires asking the right questions, observing your users, and ranking their needs by priority level.

Person staring at a screen and holding a pen

2020년8월4일

10 Steps to Conducting a Use-related Risk Analysis as Part of Your Human Factors Engineering Process

Use-related risk analysis (URRA) is a cornerstone activity for a thorough human factors engineering (HFE) process that meets the expectations set forth by US FDA and international reviewers.

2020년7월21일

Switzerland Approves MedDO Revision and Moves Toward MDR Harmonization

New legislation is being rolled out in stages to match changing European regulations and prepare the ground for a mutual recognition agreement.

2020년7월21일

US FDA 2020 Agenda Includes ISO 13485 Harmonization, De Novo Classification Scheme

The US Food and Drug Administration plans a final rule for De Novo medical device classification as well as a proposed rule for closer harmonization to ISO 13485:2016 quality management system requirements for later in 2020.

2020년7월10일

US FDA Extends UDI Deadlines for Low-risk Medical Devices

FDA focusing on coronavirus pandemic response, UDI implementation for higher-risk medical devices. Learn more about Unique Device Identification regulations at Emergo by UL.

2020년7월9일

Blended Approaches to Medical Device, IVD and Combination Product Usability Testing

An overview of in-person as well as virtual usability testing considerations for medical device, IVD as well as combination product manufacturers.

2020년7월6일

Virtual Comfort: The Key to Successful Remote Usability Testing

How and what to provide usability test participants to obtain reliable and valid results in an era of remote and virtual interactions. Learn more at Emergo by UL's Human Factors Research & Design.

2020년6월24일

Design Verification and Validation Versus Human Factors Validation

In the complex world of medical device regulation, it can be difficult to keep things straight when it comes to product development.

Product testing room for medical devices

2020년6월23일

Procedures for Conducting In-Person Usability Testing During COVID-19 Pandemic

Like many other human factors professionals, we paused in-person research for a couple of months as COVID-19 gained an increasing foothold on the world.

Two people in a conference room testing medical equipment

2020년6월22일

The European MDR and Human Factors Engineering: Evaluation of User Interface of Unknown Provenance (UOUP)

How medical device manufacturers can determine whether they qualify for UOUP designation in order to demonstrate conformity to IEC 62366, which is necessary for European MDR compliance.

2020년6월16일

European Commission Issues Decision on Harmonized Standards for MDR, IVDR

On May 15th, 2020, the European Commission published their Implementing Decision M/565 on harmonization of standards

2020년6월15일

Usability Considerations When Creating a “Go Baby Go” Car

A robotics project to help children with mobility issues offers practical lessons in human factors engineering (HFE) design.

뉴스

필터링 기준

Understanding Customers and Their Needs in Human Factors Engineering

10 Steps to Conducting a Use-related Risk Analysis as Part of Your Human Factors Engineering Process

Switzerland Approves MedDO Revision and Moves Toward MDR Harmonization

US FDA 2020 Agenda Includes ISO 13485 Harmonization, De Novo Classification Scheme

US FDA Extends UDI Deadlines for Low-risk Medical Devices

Blended Approaches to Medical Device, IVD and Combination Product Usability Testing

Virtual Comfort: The Key to Successful Remote Usability Testing

Design Verification and Validation Versus Human Factors Validation

Procedures for Conducting In-Person Usability Testing During COVID-19 Pandemic

The European MDR and Human Factors Engineering: Evaluation of User Interface of Unknown Provenance (UOUP)

European Commission Issues Decision on Harmonized Standards for MDR, IVDR

Usability Considerations When Creating a “Go Baby Go” Car

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필터링 기준

Understanding Customers and Their Needs in Human Factors Engineering

10 Steps to Conducting a Use-related Risk Analysis as Part of Your Human Factors Engineering Process

Switzerland Approves MedDO Revision and Moves Toward MDR Harmonization

US FDA 2020 Agenda Includes ISO 13485 Harmonization, De Novo Classification Scheme

US FDA Extends UDI Deadlines for Low-risk Medical Devices

Blended Approaches to Medical Device, IVD and Combination Product Usability Testing

Virtual Comfort: The Key to Successful Remote Usability Testing

Design Verification and Validation Versus Human Factors Validation

Procedures for Conducting In-Person Usability Testing During COVID-19 Pandemic

The European MDR and Human Factors Engineering: Evaluation of User Interface of Unknown Provenance (UOUP)

European Commission Issues Decision on Harmonized Standards for MDR, IVDR

Usability Considerations When Creating a “Go Baby Go” Car

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감사합니다! 요청이 접수되었습니다.