UL Solutions provides medical device testing for safety and performance, as well as certification and regulatory compliance support for medical product manufacturers and healthcare companies.

Our medical device testing offerings for performance and safety are designed to help medical device and laboratory equipment manufacturers demonstrate compliance with relevant standards and requirements. Regulators update their requirements frequently, while the healthcare sector strives to adapt to connected and evolving technologies that impact product safety and performance.

Medical Device Performance and Safety Testing

Medical Device EMC Testing and Certification

CE Marking Certification for Medical Devices and IVDs

Medical Device Single Audit Program (MDSAP)

Quality Management System (QMS) Audit Service

Medical Cybersecurity Assurance Program (CAP)

SaMD and Health Software Certification

INMETRO Certification Requirements for Medical Devices