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Medical Device Performance and Safety Testing

Performance, safety testing, certification and regulatory compliance services for medical, healthcare devices and laboratory equipment.

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

Our performance and safety testing solutions 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 deliver safer products and stay up to date with evolving standards, regulations and directives.

We can help you with:

Product performance and safety testing to standards such as:

  • IEC/AAMI 60601, Medical electrical equipment - General requirements for basic safety and performance
  • IEC 60601-1-2, Electromagnetic compatibility (EMC), wireless testing, coexistence
  • 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, the Standard for medical device software
  • IEC 62366-1, the Standard for 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, such as:

  • AAMI EC12, Disposable ECG electrodes
  • ASTM E1112, Standard specification for electronic thermometer for intermittent determination of patient temperature
  • Algorithm reproducibility process (for medical AI) 
  • UL Marketing Claim Verification

Medical regulatory compliance services, including:

  • CE Compliance – MDD, MDR and 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, risk management for medical devices registration
  • IEC 62304, medical device software — software life cycle processes registration

Other healthcare industry testing solutions, such as:

  • Biocompatibility testing and evaluation of medical devices
  • Reprocessing of reusable medical devices 
  • Process control and validation related testing
  • Ophthalmic implants — intraocular lenses

Downloads

Medical

Medical Testing Services Overview Brochure (English)

1.98 MB bytes

Why partner with UL Solutions? 

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.

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 US FDA ASCA-accredited testing laboratories including UL LLC in the US, 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 (EMC, wireless, safety, interoperability, cybersecurity, biocompatibility), and Global Market Access.

To learn more, contact us.

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