From sterile gauze and bandages to more complex devices such as bone screws; contact lenses; and orthopedic, dental and other implantable devices, UL's experience in clinical evaluations will help manufacturers develop products that will keep patients healthy. We also offer technical documentation services that enable medical device manufacturers to demonstrate product safety to regulatory authorities around the globe.
UL is accredited as a Clinical Research Organization (CRO) for medical devices under the EU Medical Device Directive (MDD) and Active Implantable Medical Devices (AIMD) directive and ISO 17025 for collection of clinical data.
MDT, a UL company, is accredited as a CRO for medical devices under the MDD and AIMD and ISO 17025 for collection of clinical data in humans.
UL clinical services are flexible and comprehensive, so we can complete all aspects of the sponsor's clinical investigations or take on one selected area where you may need more support.
UL's family of companies can provide clinical services for both pre-market and post-market clinical investigations. This includes European MEDDEV 2.12/2 studies and FDA-mandated PAS and CFR 522 studies.
By working with UL for your clinical, nonclinical, safety, EMC and management systems registration, you can save time by working with one vendor who understands your device and business.