Insights

May 17, 2023

Global Impact of (EU) Regulation 2023/607

Based on the glacial progress, delays with regulatory compliance, and paucity of notified bodies, (EU) Regulation 2023/607 was promulgated in mid-March to provide a longer transition timeline for manufacturers with legacy devices in the EU.

May 17, 2023

Webinar Debrief: Making the Most of Your Investment in Human Factors

Further analysis of "must-have" HFE capabilities versus the benefits of more extensive investments in human factors engineering resources for medical device companies

May 17, 2023

Wiklund's Perspective: HFE for Medical Devices

A look at how human factors engineering has evolved to become part of the medical device industry vocabulary

May 16, 2023

Emergo HFR&D at the 2023 HFES International Symposium on Human Factors and Ergonomics in Health Care

Part 2 of our report on key human factors engineering themes at the 2023 HFES conference

May 14, 2023

Ongoing Collaboration Between Emergo by UL and the CMTC for Medical Device Usability Testing in China

Emergo by UL's Human Factors Research & Design team has been working with the Shanghai Center for Medical Testing and Inspection (CMTC) since 2020

May 14, 2023

Retroactive Interference in Training Decay Periods

How human factors engineering professionals can employ retroactive interference techniques to improve training outcomes

May 14, 2023

Understanding Different Users in Different Countries: Clinical Practice and Healthcare Systems

How medical device use and development are affected by differences in healthcare systems and clinical practices in different markets

Applying Human Factors Engineering (HFE) to in vitro diagnostic (IVD) products under the European IVD Regulation (IVDR)

Apr 25, 2023

What is the IMDRF Regulated Product Submission for Medical Devices?

A look at the International Medical Device Regulators Forum's progress developing the RPS for regulatory submissions

Final rules for combination products, patient reports for medical device evaluation

Apr 19, 2023

Conducting Sharps Injury Prevention Tests

Injury prevention features and testing for injection devices

Apr 19, 2023

Right-sizing a Human Factors Engineering Consultancy’s Quality Management System

An in-depth look at how human factors engineering (HFE) consultancies can go about modifying their quality management systems (QMS) to better target medical device and technology projects

Apr 18, 2023

Eye Tracking: Medical Devices Through the User's Eyes

How eye tracking technology can be applied to enhance medical device safety and usability

Graphic depicting correct and incorrect ways of wearing a mask

Apr 18, 2023

Webinar Debrief: Designing Effective Quick Reference Guides

Quick Reference Guides (QRG) to help users and patients understand Instructions for Use

Person working at a laptop while checking a clipboard.

Apr 7, 2023

Leveraging Other Medical Device Regulatory Authorizations for New Market Access

Has it become vogue to leverage other regulators’ authorizations for medical device market access?

Proposed US FDA program targets medical device supply chain shortages

Apr 7, 2023

Successful Introduction of Novel Medical Devices to the US Market

Regulatory and reimbursement considerations for marketing novel medical devices in the US

Apr 3, 2023

The Global Aspect of Essential Principles for Medical Device Regulation

An examination of Essential Principles for medical device regulation across global markets

Mar 16, 2023

How Can We Define Successful Task Completion Within a Usability Test?

Suggestions for defining task completion and measuring completion rates in medical device usability testing

Mar 10, 2023

Wiklund's Perspective: Applying Human Factors to the Wide Spectrum of Life Science Products

How human factors engineering and usability practices can impact life sciences beyond medical devices

Feb 24, 2023

US FDA Annual Report: Nearly 6,000 Medical Device Authorizations in 2022

FDA annual report shows depth and breadth of Center for Devices and Radiological Health (CDRH) medical device activities through 2022

Feb 22, 2023

Expectations for Post-Market Surveillance (PMS) in the European MDR

What’s the status of your EU MDR Article 86 Periodic Safety Update Report (PSUR)? Class IIa legacy devices are approaching the deadline of their first PSUR, whereas Class III and IIb legacy devices should already have their first PSUR issued.

Feb 13, 2023

The HFR&D Process for Conducting Root Cause Analysis

Our Human Factors Research & Design (HFR&D) team's seven-step process for analysis of root causes of medical device use-related issues

Insights

Global Impact of (EU) Regulation 2023/607

Webinar Debrief: Making the Most of Your Investment in Human Factors

Wiklund's Perspective: HFE for Medical Devices

Emergo HFR&D at the 2023 HFES International Symposium on Human Factors and Ergonomics in Health Care

Ongoing Collaboration Between Emergo by UL and the CMTC for Medical Device Usability Testing in China

Retroactive Interference in Training Decay Periods

Understanding Different Users in Different Countries: Clinical Practice and Healthcare Systems

What is the IMDRF Regulated Product Submission for Medical Devices?

Conducting Sharps Injury Prevention Tests

Right-sizing a Human Factors Engineering Consultancy’s Quality Management System

Eye Tracking: Medical Devices Through the User's Eyes

Webinar Debrief: Designing Effective Quick Reference Guides

Leveraging Other Medical Device Regulatory Authorizations for New Market Access

Successful Introduction of Novel Medical Devices to the US Market

The Global Aspect of Essential Principles for Medical Device Regulation

How Can We Define Successful Task Completion Within a Usability Test?

Wiklund's Perspective: Applying Human Factors to the Wide Spectrum of Life Science Products

US FDA Annual Report: Nearly 6,000 Medical Device Authorizations in 2022

Expectations for Post-Market Surveillance (PMS) in the European MDR

The HFR&D Process for Conducting Root Cause Analysis

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