The safety of medical devices extends beyond electrical safety so that the people who are using and applying the medical device must be able to do so safely and effectively. There are several terms commonly used to describe the science behind incorporating effective and safe use into a device’s design, including “usability,” “human factors engineering (HFE)” and “ergonomics.” HFE has been added to regulatory requirements to reduce medical device use error, create more operator friendly and intuitive devices and reduce the training costs for both manufacturers and end-users.

Regulatory Requirements

Demonstrating safe use through Human Factors Engineering is one of the key components required by the major regulatory agencies. Requirements for HFE are included in IEC 60601 3rd edition and IEC 60601-1-6. The 3rd edition requires compliance with the collateral standards to achieve compliance with the main standard. FDA has published guidance on HFE requirements for FDA submissions. It also has published a list of the 16 device categories that the agency will look for HFE or Usability studies.

Standards for Human Factors Engineering

  • ANSI/AAMI HE 75:2009, Human factors engineering – design of medical devices. Provides detailed guidance on how to perform specific human factors analyses and provides a wealth of design principles
  • ISO/IEC 60601-1-6, General requirements for basic safety and essential performance – Collateral standard: Usability
  • ISO/IEC 62366:2007, Medical devices – application of usability engineering to medical devices.

 

SERVICES

Our staff of experts offer several types of tests and issue an informative report, including:

  • Conduct summative usability tests
  • Conduct design critiques
  • Assess and mitigate use-related risk
  • Prepare documentation
  • Deliver workshops and seminars
  • Define a vision of the user experience
  • Identify specific user needs
  • Create a user research strategy plan
  • Provide usability guidance during implementation
  • Provide user interface design support
  • Conduct early-stage user experience research

 

WHY UL

Global Market Acceptance

  • 120 year business experience
  • Operates in more than 143 countries
  • UL has issued more CB Test Certificates than any other body
  • UL reports and certifications are recognized and accepted around the world
  • UL Marks appear on more than 22 billion products globally
Comprehensive Testing & Certification Services

  • UL offers field evaluations, onsite training and can come to you for testing
  • Full compliance testing/evaluation to pre-scans and other preliminary testing
  • UL has engineers that work with you from design through conception and production
  • UL’s engineers average 10 plus years in the industry
  • UL has over 11 industries business units in the UL company portfolio

 

Knowledge of Global Standards and Regulatory Requirements

  • Covers many markets ie FDA (US), MFDS (Korean FDA), EU IVD, EU MDD
  • UL has helped to set more than 1,600 standards defining safety, security, quality and sustainability
  • UL Engineers partner with standard committees such as AAMI, ANSI and government bodies
  • UL has an FDA recognized consensus standard, UL 2900, for cybersecurity
State of the Art Facilities

  • 159 UL laboratories for testing and certification world wide
  • Tailored testing solutions, using software automation to enhance process efficiency, analyze results and reduce testing cycles
  • Over 10 Accredited UL laboratories around the world

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**As a Notified Body, MDSAP Recognized Auditing Organization and ISO 17000 series accredited Certification Body we cannot participate in the design, manufacture, installation or distribution of the products we certify or provide consultancy services related to those products. In addition, the UL Notified Body cannot provide certification services to companies that have been provided with consultancy services from other companies in the UL family. We also cannot link our activities to the activities of organizations that provide consultancy services. If you require such services please use an internet search engine to identify relevant providers.