Our dedicated team are one of the most experienced in the industry. 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 ensure compliance with complicated quality regulations that could otherwise lead to recalls, embargoes, bans and liability. We offer ISO 13485 quality system certification to support global regulatory requirements.  We offer nonclinical testing; usability, EMC and performance testing; safety certification; and compliance training to help speed unrestricted access to the global market.

Our Notified Body supports EU Market Access under the MDD, IVDD and revised EU Medical Device and IVD Regulations.  Learn more about critical considerations when choosing a Notified Body.  Click here to download the article.

The benefits of working with UL
UL works directly with government agencies around the globe to help inform health IT policy around cybersecurity and interoperability. Our technical experts are active members of industry standards writing and technical committees.

Our global presences enables us to offer our customers testing, regulatory and certification 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.

See what our customers have to say about working with UL.

“The entire team exceeded my expectations in all areas involved. Everyone was very responsive which is key because there are always project deadlines to be met.”-  Steve Grimes, Product Compliance Engineer, Brady Corporation Milwaukee, WI

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Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries.  This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers.  UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.  Read more about this.

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INDUSTRY INSIGHTS see all

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

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Testing and Evaluation Strategies for the Biological Evaluation of Medical Devices Submitted for CE Mark and FDA Approval
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The Changing Landscape of Medical and In Vitro Diagnostic Device Regulations in the European Union
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Medical Device Approvals in Brazil: A Review and Update
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UL 2560 and Emergency Call Systems: Expanding the Standards Framework
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Physical and Chemical Characterization: The First Stage in Assessing the Biocompatibility of Medical Device Materials
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