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; 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

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

Earlier this year, the IEC finalized and published the latest edition of IEC 60601-1-11:2015, the Collateral standard for medical devices used in the Home Healthcare environments. Manufacturers of applicable devices need to consider the additional risks posed as more devices move to support patients and health outside of the clinical environment, including ease of use,...

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Globally, UL Registrar is ACLASS/ANAB Accredited by the ANSI-ASQ National Accreditation Board to provide the ACLASS Symbol for a variety of technical schemes, which highlights UL Registrar’s technical competence as a monitoring body. Throughout the world, many countries rely on a process called accreditation as a means of confirming the technical competence of inspection/audit bodies...

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In February, the International Electrotechnical Commission (IEC) published the fourth edition of IEC 60601-1-2,  a collateral standard that provides the requirements for essential performance and basic safety in the presence of electromagnetic disturbances. The standard introduces electromagnetic (EM) environments of “intended use”, including professional healthcare facilities and home healthcare.  Although the FDA transition date is...

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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...
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...
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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