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; 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. 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.

AREAS OF FOCUS

INDUSTRY INSIGHTS see all

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

Achieving Global Approvals for mHealth Devices and Products
Achieving Global Approvals for...
Applying Human Factors Engineering to Produce Safer and More Effective Products
Applying Human Factors Enginee...
Choices – IEC 60601-1 3rd Edition and Component Selection
Choices – IEC 60601-1 3rd Ed...
Home Healthcare Equipment: An Overview
Home Healthcare Equipment: An ...
Medical Device Approvals in Brazil: A Review and Update
Medical Device Approvals in Br...
Physical and Chemical Characterization: The First Stage in Assessing the Biocompatibility of Medical Device Materials
Physical and Chemical Characte...
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Safety of Personal Hygiene & Beauty Therapy Equipment used in Commercial Settings
Safety of Personal Hygiene &am...
Testing and Evaluation Strategies for the Biological Evaluation of Medical Devices Submitted for CE Mark and FDA Approval
Testing and Evaluation Strateg...
The Changing Landscape of Medical and In Vitro Diagnostic Device Regulations in the European Union
The Changing Landscape of Medi...
The U.S. FDA’s Regulation and Oversight of Mobile Medical Applications
The U.S. FDA’s Regulatio...
U.S. Medical Device Clearance: Navigating the FDA 510(k) Premarket Approval Process for Medical Devices
U.S. Medical Device Clearance:...
UL 2560 and Emergency Call Systems: Expanding the Standards Framework
UL 2560 and Emergency Call Sys...
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