Medical Device Performance and Safety Testing

The growing complexity of medical devices and laboratory equipment requires more advanced testing and certification to evaluate safety, performance and compliance with regulatory requirements. This is critical for safe and effective patient care.

Our performance and safety testing offerings are designed to address a variety of medical device and laboratory equipment certification needs. Regulators update their requirements frequently while the healthcare sector strives to adapt to connected and evolving technologies.

Our deep technical expertise helps you demonstrate the safety of your products and stay up to date with evolving standards, regulations and directives.

Watch now: Solutions for the healthcare and life sciences industry

Dedicated to healthcare industry innovation, we leverage decades of technical, regulatory and clinical expertise to help you manage regulatory challenges and bring safer products to market faster.

We can help you with:

Product performance and 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 1069, the Standard for Hospital Signaling and Nurse Call 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 62304, Medical Device Software – Software Life Cycle Processes
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 validation and verification testing:

AAMI EC12, Disposable ECG Electrodes
ASTM E1112, Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
Algorithm reproducibility process (for medical artificial intelligence)
UL Marketing Claim Verification

Medical regulatory compliance services:

CE compliance – Medical Device Directive (MDD), Medical Device Regulation (MDR) and In-Vitro Diagnostic Devices Directive (IVDD) certifications
Medical Device Single Audit Program (MDSAP) certification
Quality management system (QMS) registration and certification for medical device manufacturers include ISO 13485 and ISO 9001
Brazil INMETRO certification
ISO 14971, Medical Devices – Application of Risk Management to Medical Devices
IEC 62304, Medical Device Software – Software Life Cycle Processes

Other healthcare industry testing services:

Biocompatibility testing and evaluation of medical devices
Reprocessing reusable medical devices
Process control- and validation-related testing
Ophthalmic implants – Intraocular lenses

Why partner with UL Solutions?

We are dedicated to healthcare industry innovation, leveraging decades of technical, regulatory and clinical expertise to help you manage regulatory challenges and bring safer products to market faster.

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 including UL LLC in the U.S., Japan and Italy.

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 (electromagnetic compatibility (EMC), wireless, safety, interoperability, cybersecurity, biocompatibility) and Global Market Access.

To learn more, contact us.

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