知見 | Emergo by UL

2024年4月5日

2024 HFES International Symposium on Human Factors and Ergonomics in Health Care Takeaways

Nearly 20 Emergo HFR&D team contributed nine presentations to the 2024 HFES International Symposium on Human Factors in Health Care, and mostly spent time in the Medical and Drug Delivery Devices (“MDDD”) track.

Doctor shaking a person's hand inside a hospital

2024年4月2日

First Quarter of 2024: Global Medical Device Regulatory Harmonization is the Theme

Global regulatory harmonization for medical devices appears to be the theme to start the year. Read Emergo by UL’s 2024 medical device regulatory insights.

Software as a medical device (SaMD) x-ray images

2024年4月2日

Webinar debrief: Applying Human Factors Engineering to Software as a Medical Device

On March 20, 2024, our Senior Research Director Merrick Kossack and Design Director Cory Costantino delivered a webinar on applying human factors engineering to software as a medical device. This debrief highlights some key topics presented.

World map on globe with push pins for locations

2024年3月27日

Emergo by UL's Key Takeaways from the Finalized Version of China's NMPA HFE guidance

On March 19th, 2024, China’s National Medical Products Administration (NMPA) Center for Medical Device Evaluation (CMDE) released a finalized version of its guidance about the application of human factors engineering (HFE) / usability engineering (UE) to medical device development. In this succinct article, we address the changes and updates from the prior draft guidelines for public comment, released in October 2023.

Concord Usability Lab's clinical product observation room

2024年3月27日

New Guidance on Clinical Investigation Plans for Medical Devices

The recitals of the Medical Devices Regulation (MDR) (EU) 2017/745 explain the importance of aligning clinical investigation provisions with ISO 14155.

Drawing of computer displaying charts and graphs

2024年3月8日

MHRA Update on Classification of Software as a Medical Device (SaMD)

MHRA confirmed they will adopt the risk categorization in IMDRF: "Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations.

Human hand holding a set of instructions

2024年3月5日

Using Desk-based Readability Assessments to Evaluate the Labeling of Medical Devices

Desk-based readability assessments are a time and resource-effective method of evaluating the readability of your labeling, including your instructions for use (IFU), quick reference guide (QRG) or other user-facing documents (e.g. patient information leaflets). In this article, Emergo by UL discusses the applications of readability assessments and presents an overview of three methods.

2024年2月29日

Webinar Debrief: Developing HFE Strategies to Meet Global Regulations

Debriefing on a recent webinar, Emergo by UL Senior Research Directors share global considerations for cornerstone HFE activities.

Person pointing at a graph on a large tv screen

2024年2月21日

US FDA CDRH Warning Letters: A Review of 2023

Manufacturers can better understand quality and regulatory issues of concern by the U.S. Food and Drug Administration (FDA) by reviewing relevant warning letters. This can allow companies to focus on problem areas as they continually assess and improve their internal procedures and processes.

2024年1月25日

Common User Interface Design Flaws that Can Induce Use Errors

Most medical device use errors are induced by user interface design flaws and not by user ineptitude. Disbelievers need only to observe a few usability test sessions to witness the pattern of repeated use errors that particular UI design flaws can induce if the device has not already been “scrubbed clean” of such flaws.

Girl monitoring medical device patch with smartphone

2024年1月25日

Four major questions to consider when validating mobile apps with connected devices

Designers have leveraged systems thinking and technology expansion to rapidly increase the capability and complexity of our medical device and combination products. However, such developments present a real challenge today: how can we connect apps and system components to deliver products that meet a variety of users’ diverse needs effectively and safely?

2024年1月25日

The US FDA CDRH 2023 Annual Report: Summary

Emergo by UL examines the US FDA Center For Devices and Radiological Health (CDRH) 2023 annual report covering medical device regulatory developments over the past year.

知見

次の条件で絞り込み

2024 HFES International Symposium on Human Factors and Ergonomics in Health Care Takeaways

First Quarter of 2024: Global Medical Device Regulatory Harmonization is the Theme

Webinar debrief: Applying Human Factors Engineering to Software as a Medical Device

Emergo by UL's Key Takeaways from the Finalized Version of China's NMPA HFE guidance

New Guidance on Clinical Investigation Plans for Medical Devices

MHRA Update on Classification of Software as a Medical Device (SaMD)

Using Desk-based Readability Assessments to Evaluate the Labeling of Medical Devices

Webinar Debrief: Developing HFE Strategies to Meet Global Regulations

US FDA CDRH Warning Letters: A Review of 2023

Common User Interface Design Flaws that Can Induce Use Errors

Four major questions to consider when validating mobile apps with connected devices

The US FDA CDRH 2023 Annual Report: Summary

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