The UL Life & Health Sciences division is dedicated to healthcare industry innovation
- We help 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
Our technical experts and biomedical engineers each average of over 10 years’ experience and are active members of industry 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 mature technologies or new technologies.
We are the # 1 Issuer of IECEE CB Scheme Certificates and 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 non-clinical testing services from supply chain sterilization/hygiene to packaging, helping to prepare healthcare products for successful commercialization.
UL is a recognized Auditing Organization for MDSAP, simplifying global market access.
Throughout the UL family of companies, we offer services that life and health sciences companies need for business success and improving patient outcomes. From sustainability services and security to product safety, and quality management system registration, UL has an offering. We can even serve as your project manager to coordinate several UL services on your behalf, saving you time and resources.
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
TO TALK WITH OUR IN-HOUSE SUBJECT-MATTER EXPERTS AND TAKE ADVANTAGE OF OUR PERSONALIZED, NO-OBLIGATION CONSULTATION, 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.
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:
B… [Read more]
Medical devices delivered in a sterile state must be designed, manufactured, and packed to ensure they are sterile when placed on the market. However, device packaging can degrade over time or become compromised during packing, transportation, distribution, storage or handling. Many device r… [Read more]
The clinical evaluation is an essential part of the technical documentation, which manufacturers are required to use to document their compliance with the general safety and performance requirements. The new medical Device Regulations places greater emphasis on the use of clinical data to de… [Read more]