Medical Device Safety Testing, Certification and Regulatory Compliance

UL Solutions leverage decades of technical, regulatory and clinical expertise to help you manage regulatory challenges and bring safer products to market faster.

• Our technical and regulatory expertise can help medical device manufacturers establish regulators’, patients and users’ trust in their devices’ safety and performance claims.
• Our global testing laboratories are accredited by the U.S. Food and Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA) and offer local support to help you meet U.S. healthcare market regulations with fewer delays.
• Our engineers work closely with standards committees, including the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI) and the International Electrotechnical Commission (IEC), to stay current on all new and upcoming changes.
• We provide a single source for your needs, helping you save time and money. Our comprehensive suite of services includes end-product testing, certification, validation (EMC, wireless, safety, interoperability, cybersecurity, biocompatibility), and Global Market Access.