Choosing the right medical device testing laboratory for your needs
The growing complexity of medical devices and laboratory equipment requires more advanced testing to evaluate safety, performance and compliance with regulatory requirements. This is critical for safer and more effective patient care.
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.
Innovative approaches to medical equipment safety testing
Our deep technical expertise allows us to offer you the right medical equipment testing approach to help you demonstrate the safety and performance of your products. Work with us to stay current with evolving standards, regulations and directives.
Watch now: Effective safety compliance strategies for the health and life sciences industry
Dedicated to healthcare industry innovation, we leverage decades of technical, regulatory and clinical expertise to help you to navigate your medical device safety testing needs, manage regulatory challenges and bring safer products to market faster.
Medical device testing services: Assessing safety and performance
Our comprehensive suite of medical device testing and certification services includes end-product testing, certification, validation (electromagnetic compatibility (EMC), wireless, safety, interoperability, cybersecurity, biocompatibility) and Global Market Access.
We can help you with Medical equipment safety testing to standards, such as:
IEC/AAMI 60601, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-2, Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests
IEC 61010, Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use
IEC 61326-1, Electrical Equipment for Measurement, Control and Laboratory Use – EMC Requirements – Part 1: General Requirements
IEC 61326-2-6, Electrical Equipment for Measurement, Control and Laboratory Use – EMC requirements – Part 2-6: Particular Requirements – In Vitro Diagnostic (IVD) Medical Equipment
UL 2560, the Standard for Emergency Call Systems for Assisted Living and Independent Living Facilities
UL 1431, the Standard for Personal Hygiene and Health Care Appliances
IEC 62366-1, Medical Devices – Part 1: Application of Usability Engineering to Medical Devices
ANSI/CAN/UL 2900-1, the Standard for Software Cybersecurity for Network-Connectable Products, Part 1: General Requirements
ANSI/CAN/UL 2900-2-1, the Standard for Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems
Customized medical device validation and verification testing:
AAMI EC12, Disposable ECG Electrodes
ASTM E1112, Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
Medical regulatory compliance services:
CE compliance – EU Medical Device Directive (MDD), Medical Devices Regulation (MDR), In-Vitro Diagnostic Medical Devices Directive (IVDD) and In Vitro Diagnostic Medical Devices Regulation (IVDR) certifications
Quality management system (QMS) registration and certification for medical device manufacturers include ISO 13485 and ISO 9001
ISO 14971, Medical Devices – Application of Risk Management to Medical Devices
Other healthcare industry testing and medical device services:
Ophthalmic implants – Intraocular lenses
The role of regulatory standards in medical device safety testing
Our testing and compliance engineers work closely with standards committees to stay up-to-date on all the new amendments and upcoming changes. These committees include the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI) and the International Electrotechnical Commission (IEC). UL Solutions has several U.S. Food and Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA)-accredited testing laboratories in the U.S., Japan and Italy.
Why work with UL Solutions?
The advantages of choosing UL Solutions for medical device testing are many. Here are some of the top reasons medical device manufacturers choose us for their medical testing needs.
Benefits of working with a safety science leader:
Rely on our 100+ years of experience in safety testing
Depend on our decades of expertise in medical device testing
Choose tailored medical device testing approaches
Demonstrate performance and effectiveness to potential customers
UL_Solutions_Medical_Testing_Services_Overview_Brochure.pdf
8.1 MB
Transitioning_to_60601_amendment_2_-_Infosheet_EN.pdf
470 KB
Make_the_Change_to_UL_Solutions_Infosheet.pdf
480 KB
Healthcare-Cybersecurity-Quick-Sheet.pdf
540 KB
GMA_CB_Scheme_Brochure.pdf
5.8 MB
CS435723_-_UL_Solutions_non_clinical_infosheet_FINAL.pdf
530 KB
X
Get in touch
Have questions, need specifics? Let's get this conversation started.
Please wait…