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Human Factors: Global Considerations & Regulatory Requirements

The study of Human Factors is intended to increase safety and minimize risks associated with product use errors through avoidance of intended and/or unintended mistakes. Within the realm of medical devices, design-induced errors can lead to ineffective therapies, injury or death to patients and healthcare personnel alike. As such, the importance of Human Factors and Usability Engineering has become increasingly recognized by global regulatory authorities as a design requirement.

However, in spite of regulatory requirements and guidance, Human Factors is still often overlooked by medical device manufacturers, or considered only at the last moment when a regulatory agency expresses concern. This is apparent when considering that the FDA alone receives 100,000 medical product incident reports annually, with more than one-third attributed to use errors.

NAMSA invites you to access our latest White Paper, “Human Factors: Global Considerations & Regulatory Requirements,” to learn how the field of Human Factors and Usability Engineering pertains to medical device design, and to gain a better understanding of:

  • Human Factors Medical Device Regulations (U.S. FDA and EU MDD / MDR)
  • ISO Standards
  • Practical Steps to Address Human Factors Design & Development
  • Robust Identification Process
  • Formative Usability Evaluation
  • Use-Related Hazards and How to Reduce/Eliminate
  • Final Validation Testing
  • Data Analysis to Create Usability Reports

Please fill out the form below to access this white paper.