UL Life & Health SciencesThe UL Life & Health Sciences division is dedicated to healthcare industry innovation by helping clients with their biggest challenges in regulatory management, market access, and connected device risk i.e. safety, security, usability, and interoperability. We ensure that medical devices are safe to deploy and use in an increasingly patient-centric and connected environment.

UL brings decades of the most advanced technical, regulatory and clinical expertise to solve the toughest challenges in the market with the goal of improving access to advanced safe healthcare around the world.

The benefits of working with UL

UL Life & Health Sciences

  • Our technical experts and biomedical engineers each average of over 10 years’ experience and are active members of international standards writing and technical committees. This gives our customers the benefit of anticipating changes to the standards and regulations and having representation during development.
  • UL bases all testing methods using sound engineering principles and experience in the field of Electrical, Mechanical, Chemical, Computer Science, and Microbiology whether they come from existing standards for mature technologies or new technologies.
  • We are the # 1 Issuer of IECEE CB Scheme Certificates
  • We have ISO 17025 accredited laboratories around the world. Our global presence enables us to offer our customers testing, regulatory, and certification services in native languages and local time zones as well as being able to provide access to local experts.
  • The UL 2900 2-1 Cybersecurity standard is a US FDA Consensus standard and is leveraged globally by connected medical device manufacturers.
  • We offer a full range of medical device testing services from supply chain sterilization/hygiene and packaging, to electrical, to cyber, all helping to prepare healthcare products for successful commercialization.
  • UL is a recognized Auditing Organization for MDSAP, simplifying global market access.

SEE WHAT OUR CUSTOMERS HAVE TO SAY ABOUT WORKING WITH UL.

"I can tell you, after working with other organizations, the reason I have worked with UL for so many years is the great people. Over the years their experience, knowledge, and great project work has developed into a great and lasting relationship."

- Theophilos Theophilou, Operations Manager & Director of QA/RA, SOURCE-RAY, INC. New York, NY

"Early engagement and in-house design review with UL engineer (Alex Mlynski) was very helpful. I would recommend this approach for all large or complex devices going to UL."

- Ben Sutton, Planet Innovation

"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

TO SPEAK WITH OUR INDUSTRY LEADERS AND TAKE ADVANTAGE OF A PERSONALIZED, NO-OBLIGATION ANALYSIS, CLICK HERE.

**As a Notified Body, MDSAP Recognized Auditing Organization and ISO 17000 series accredited Certification Body we cannot participate in the design, manufacture, installation or distribution of the products we certify or provide consultancy services related to those products. In addition, the UL Notified Body cannot provide certification services to companies that have been provided with consultancy services from other companies in the UL family. We also cannot link our activities to the activities of organizations that provide consultancy services. If you require such services please use an internet search engine to identify relevant providers.

RECORDED WEBINARS

RECORDED WEBINAR: Strategy for Biological Safety Evaluation of Medical Devices

Biological safety evaluation of medical devices is a part of regulatory requirement. The scope of the webinar is to understand the strategy behind the biocompatibility testing and a step wise approach to implement biocompatibility requirements. The topics covered are as follows: Biocompatibility strategy Role of material characterization Biocompatibility studies and Toxicology risk assessment   Register… read more

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