Emergo by UL News

Nov 6, 2020

Six Everyday Products Initially Developed as Assistive Technology: Designing for Typically Excluded Users

In terms of medical device and IVD human factors engineering (HFE), usability and design, targeting "typically exclused" users can improve overall product benefit. Learn more at Emergo by UL's Human Factors Research & Design.

Nov 4, 2020

MDSAP Council Updates Guidance on Conformity Assessments and Related Requirements

The participating regulators in the medical device single audit program (MDSAP) issued a new guidance documents that is consolidated from two existing documents and expanded with additional annexes.

Nov 2, 2020

Brexit and the UK’s Medical Device Usability Requirements

Examination of how the UK Medicines and Healthcare products Regulatory Agency (MHRA) will oversee medical device human factors engineering (HFE) and usability regulations following Brexit.

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Oct 20, 2020

Essential Differences Between Heuristic Analysis and Expert Review

For manufacturers of medical devices, combination products, and IVDs, heuristic analysis and expert review are both approaches that make it possible to refine a product design before exposing it to potential users.

Elderly woman measuring her blood pressure

Oct 8, 2020

Enabling Safe and Effective Diagnostic Tests, Treatments and Monitoring at Home

Increasing utilization of at-home healthcare products and telemedicine require new approaches to human factors, usability and design of medical devices. Learn more at Emergo by UL's Human Factors Research & Design division.

Oct 6, 2020

How to Consider Diversity and Inclusion (D&I) When Applying Human Factors Engineering to Medical Products

Incorporating D&I in your medical device HFE, design and usability effort helps your product target the widest user base possible.

Sep 30, 2020

An Assessment of the Proposed Rule to Change US FDA’s Interpretation of Intended Use

Analysis of FDA's proposed new definition of Intended Use concepts pertaining to medical devices and drugs, and recommendations for how manufacturers can prepare for possible changes.

Sep 29, 2020

2020 Amendments to IEC 62366 – Implications for Medical Device Usability Engineering

Examination of recent amendments to the IEC 62366 standard for medical device usability engineering and how manufacturers are impacted. Learn more at Emergo by UL's Human Factors Research & Design (HFR&D) unit.

Sep 22, 2020

Japan PMD Act Revisions Include Fast-track Reviews for Some Medical Devices and IVDs

Fast-track Japan PMDA registration now open for qualifying medical device and IVD manufacturers as PMD Act revisions begin taking effect.

Sep 15, 2020

US FDA Updates Final Guidance on ISO 10993 for Medical Device Biocompatibility

Final FDA guidance on ISO 10993-1 for biological evaluation of medical devices gets an update. Learn more about US medical device regulations at Emergo by UL.

NMPA publishes revised Chinese medical device regulations

Sep 4, 2020

Medical Device Usability Testing in China: Key Considerations for Manufacturers

New usability testing guidelines from China national medical products administration (NMPA) anticipated by late 2020. Learn more about China's medical device market and human factors engineering issues at Emergo by UL.

Sep 4, 2020

Self-Selection Studies: Guarding Against Contraindicated Use of OTC Medical Products

Recommendations for devising self-selection studies necessary to help consumers understand OTC medical product indications for use.

Sep 3, 2020

UK MHRA Issues New Guidance on UK REP and Medical Device Regulatory Compliance

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has posted new guidance regarding medical devices placed on the market in Great Britain

Aug 19, 2020

Updated European UDI FAQ Features Revised Compliance Deadlines

The European Commission has published a guide featuring complete timetables that incorporate recent regulatory postponements.

Aug 18, 2020

Understanding Sufficient Clinical Evidence Requirements Under the European Medical Devices Regulation

Considerations for medical device manufacturers ahead of MDR compliance for ensuring adequate clinical data management, including post-market clinical follow-up (PMCF) activities.

US FDA readies transition plans for COVID-19 medical device enforcement policies

Aug 11, 2020

US FDA Medical Device User Fees Increase 7% for 2021

FDA user fees for the agency's 2021 fiscal year increase by seven percent, including for small-business applicants. Learn more about US FDA regulatory issues at Emergo by UL.

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Aug 7, 2020

Human Factors Considerations When Developing Rapid COVID-19 Test Kits

Rapid COVID-19 test kit manufacturers should include human factors and usability components in their product development processes.

Aug 6, 2020

Has FDA Relaxed Its Human Factors Expectations in Response to the COVID-19 Pandemic?

There are several key activities required by the US Federal Drug Administration (FDA) to meet its expectations for the application of human factors (HF) engineering to medical devices.