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
Overhead view of a group of people working at a long wooden table

White Papers

Our industry-leading research will share insights for success in a dynamic and demanding market.

Contact us
Filter by Loading...
Filter
Clear all
X
Filter by
Service (0)
Open
Market (0)
Open
Reset all
Done
Reset all
A technician scans the barcodes on medicine boxes

Introduction to South Korea’s Medical Device UDI System

This white paper discusses the basics of South Korea’s Unique Device Identifier (UDI) regulation and recommends steps...
Colleagues collaborating in front of a laptop

Cybersecurity and U.S. FDA Software as a Medical Device Regulations

This white paper provides an overview of FDA cybersecurity control requirements in support of marketing submissions for...
Business colleagues collaborating in a glass walled office

Vigilance Reporting in the European Economic Area, Switzerland and the United Kingdom

This white paper explains key compliance issues for medical device manufacturers regarding vigilance reporting across...
A doctor shaking hands with a business professional while another doctor has a meeting in the background

Overview of India’s Medical Device Regulatory Framework

Learn more about India CDSCO medical device regsistration and approval requirements.
Person in a suit pointing to reports laying on a conference table during a meeting

Amendments to the Pharmaceuticals and Medical Devices Act in Japan

This white paper highlights how medical device and IVD manufacturers are impacted with the amendments to the PMD Act in...
Young person testing their blood sugar with their mobile phone.

Stand-alone Medical Software Compliance

This white paper provides an overview of IEC 62304, IEC 60601 and IEC 82304 standards for software.
Three business professionals at a table having a meeting

Pathway to MDSAP Whitepaper

Learn more about the steps in the MDSAP transition process.
Three business people at a table having a meeting

Guide to US FDA Requirements for Novel and Innovative Medical Devices

This white paper covers the US FDA regulations for manufacturers of novel and innovative medical devices and...
Person reviewing paperwork

US FDA and MDSAP Inspections for Medical Device Manufacturers

Prepare for US FDA and MDSAP inspections and help meet compliance with our expert guide.
Manager reviewing reports by laying them out on a table

ISO 10993-1 and Biocompatibility

Understand ISO 10993-1 biocompatibility standards for medical devices and how to conduct a biological evaluation.
Scientists and business people talking in a conference room

Understanding Europe’s In Vitro Diagnostic Medical Devices Regulation

Learn more about EU In Vitro Diagnostic Medical Device Regulations.
Coworkers attending meeting

Early Communication with the FDA

Learn more about tips and other information to help you feel comfortable when corresponding with the FDA.
X

Request information from our specialist

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