Industry Focus

The healthcare industry is changing and we have the breadth of expertise to help you evolve with it.

Overview
Doctor listening to baby's heart
Next
Previous
Services

Comprehensive service offerings at every point in the product life cycle.

Overview
RAMS®

A platform of digital products to improve, simplify and automate RA/QA activities

Learn more
OPUS™

Emergo by UL's new human factors tool - provides training, tools, and resources.

Learn more
Software

Our software tools offer digital regulatory monitoring for medical device compliance and access to human factors engineering tools.

Overview
News

The latest industry news and insights from our global team.

View all
RADAR : Market Access Newsletter

Stay informed with the most read RA/QA medical device newsletter.

Sign up
TalkingPoints : Human Factors Newsletter

TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.

Sign up
Resources

Information and tools to advance your business.

View all
Events

Learn from our experts through live events.

View all
Doctor sitting at a desk taking notes from a labtop
Next
Previous
About

Our global consulting team works from 20+ offices on six continents.

Overview
global representation of the Earth
Next
Previous
Switch Language
Emergo by UL News

News

Get the latest global medical device regulatory news, insights from our experts and more.

Contact us
Filter by Loading...
Filter
Clear all
X
Filter by
News Type (0)
Open
Service (0)
Open
Market (0)
Open
Reset all
Done
Reset all
593 results
  • new
graphic checklist
  • Regulatory Update
Jul 17, 2025

GPAI with Systemic Risks: Additional Safeguards

In this article, we focus on the additional safeguards that apply to GPAI models with systemic risks.
  • new
Elderly person measuring their blood pressure
  • Regulatory Update
Jul 15, 2025

Mexico’s COFEPRIS Updates Low-risk and Deregulated Medical Devices List

Mexican regulators have updated the list of low-risk medical devices. Have requirements for your products changed?
  • new
Blood pressure monitors and drug test kits on display
  • Regulatory Update
Jul 14, 2025

A Shift in the Compliance Landscape: The EU GPAI Code of Practice is Here

New AI-driven healthcare devices placed on the European market must comply with the General-Purpose AI Code of Practice...
  • new
London Bridge at dusk
  • Regulatory Update
Jul 10, 2025

UK MHRA Publishes Common Specification Requirements for IVD Devices

Keep up with IVD regulations in the UK. See our analysis of the outcome of the UK medical device regulator’s...
  • new
Reading IFUs
  • Insights
Jul 7, 2025

5 Methods for Evaluating Your Instructions for Use: Benefits and Drawbacks

We provide five methods to evaluate instructions for use.
Two people in a dark office reviewing data on a computer
  • Regulatory Update
Jul 7, 2025

FDA Releases Final Guidance on Medical Device Cybersecurity

We explain the requirements of recent FDA cybersecurity guidance.
Secure data management to meet HIPAA, PHI, and requirements of Covered Entities or Business Associates.
  • Insights
Jul 3, 2025

Is it Too Bold to Refer to this as the Quarter of Data Accessibility?: Second Quarter 2025 Developments

Follow our coverage of medical device regulatory news with this examination of developments from the second quarter of...
Medical device sketch page
  • Regulatory Update
Jul 2, 2025

European Packaging Waste Legislation Repeals the Directive and Applies in Mid-2026

European medical device Regulation (EU) 2025/40 governing packaging waste was published in January 2025, and most of the...
Unique Device Identifier (UDI) label
  • Regulatory Update
Jun 27, 2025

Current State of UDI in Brazil: Review of RDC 591/2021 and RDC 884/2024

Brazil’s medical device regulator, ANVISA, enacted RDC 591/2021, which legislated the Unique Device Identifier (UDI)...
AI and MI enabled medical devices
  • Regulatory Update
Jun 24, 2025

Decoding MDCG 2025-6: Interplay Between the MDR/IVDR and AIA

The European Commission has released three new pieces of guidance on medical device software.
Equipment and glassware for test product extraction and orange color solution
  • Regulatory Update
Jun 23, 2025

EU Releases Guidance on IVD Performance Studies, Finally

The long-awaited Questions & Answers on In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) Performance...
Picture of blood pressure monitor with a reading displayed.
  • Regulatory Update
Jun 20, 2025

European Revision of Primary Software Guidance (MDCG 2019-11 Revision 1): Small Changes, Meaningful Clarifications

Our regulatory experts clarify the implications of the European Commission’s revision to its guidance on primary...
X

Request information from our specialists

Thanks for your interest in our products and services. Let's collect some information so we can connect you with the right person.