Only use this login to access MyHome, MyAgreements or ULiQ. Each option requires a different username and password.

North America
Europe
Denmark
France
Germany
Italy
Netherlands
Poland
Spain
Sweden
Switzerland
U.K.
Latin America
Asia Pacific
Argentina
Brazil
Mexico
Australia
China
Hong Kong
India
Japan
Korea
New Zealand
Broader and deeper than ever, UL's third annual global study examines manufacturer and consumer concerns and priorities across a wide range of product-related considerations.

more >
UL is proud to share New Science, a powerful initiative showcasing important ways we are making our world safer through fundamental discovery, testing methodologies, software and standards across four areas.
more >

STANDARDS

Thousands of products and their components are tested to our rigorous requirements every year.

DASHBOARD

UL's Dashboard tools enable businesses to meet evolving marketplace needs by being smarter, more efficient and faster than ever before.

learn more >

LIBRARY

MARKS HUB

SERVICES

STANDARDS

MEDICAL AND LABORATORY

UL provides comprehensive life cycle services to support the medical and laboratory industries in achieving global regulatory approvals.

Our industry-dedicated team are knowledge leaders in the full life cycle needs of the health sciences industries. Our customers gain the efficiency, expertise and cost benefits associated with working with an industry leader for all their critical business needs.

UL helps our customers prevent and resolve complicated quality issues that could lead to recalls, embargoes, bans and liability. We offer nonclinical testing; usability, EMC and performance testing; safety certification; regulatory advisory services; and compliance training to help speed unrestricted access to the global market.

The benefits of working with UL
UL’s in-depth knowledge of the issues driving regulatory efforts uniquely enables us to provide actionable insights to help our customers achieve compliance in all of their target markets.

UL works directly with government agencies around the globe to help inform health IT policy. Our technical experts are active members of industry standards writing and technical committees. We also have a cooperative research and development agreement (CRADA) with the U.S. Food and Drug Administration (FDA). Through this unique partnership, UL has provided the online training, documentation tracking and a 21 CFR Part 11-validated platform used to certify and train over 36,000 FDA inspectors worldwide.

Our global presences enables us to offer our customers a full suite of services in their own language and time zone as well as to provide access to local experts who can assist them in understanding regulatory requirements in all of their target markets. We provide integrated quality system assessments to ease the process of meeting regulatory requirements for multiple countries.

We can provide our customers with comprehensive, customized learning management systems that can be integrated directly into their compliance and quality systems to further assist them in demonstrating compliance to regulators.

UL’s Medical Quality Management System Registration Program Requirement

Areas of Focus

In Vitro Diagnostics
more >
Laboratory, Test, and Measurement and Control Equipment
more >
Medical Devices
more >
Nurse Call and Emergency Call Systems
more >
Personal Health and Hygiene Products
more >

Browse pertinent UL thought leadership to help you find the research and insights that matter for your business.

Achieving Global Approvals for...
Choices – IEC 60601-1 3rd Ed...
Home Healthcare Equipment: An ...
Medical Device Approvals in Br...
Physical and Chemical Characte...
Safety of Personal Hygiene &am...
UL 2560 and Emergency Call Sys...

LEARN MORE ABOUT OUR OFFERINGS IN THIS INDUSTRY

Industry Insightsmore >

On September 24, 2013, the U.S. FDA published the final rule requiring medical devices to have a Unique Device Identifier. Businesses must comply based on the tiered implementation deadline, established by device classification.  This requirement extends to all device manufacturers selling and marketing products in the U.S., including manufacturers exporting to the U.S.  The FDA compliance...

more >

Medical devices manufactured today require significant attention to safety and human factors engineering that has not always been exercised in medical device design. IEC safety standards mandated by the general standard, IEC 60601-1, updated to the 3rd edition, and now Amendment No. 1 to that standard, require testing and verification of devices and essential performance,...

more >

UL’s Linda Chatwin, Maureen Mulcare and Jeff Rongero, recently published an article in Medical Design Briefs titled “Safety and Human Factors Engineering in Medical Device Design.” As the article states, “Ultimately, manufacturers must validate that the product’s users can employ the device safely and effectively in the intended use environments” which is why Usability is...

more >