Why Regulatory Support is Essential for Human Factors Compliance
Human Factors and Usability are core components of medical device regulations across global markets. IEC 62366-1 and its practical guidance IEC 62366-2 require a structured process for identifying, evaluating and mitigating use-related risks throughout development. In parallel, the MDR/IVDR demand clear evidence that the product can be used safely and effectively by the intended users under real-use conditions. The FDA requires Human Factors Validation for most high-risk medical devices. Without properly planned and documented usability work, approval delays, rejections or recalls become real risks.
Fulfills IEC 62366-1, ISO 14971, MDR/IVDR, FDA and NMPA requirements
Enables traceability of user needs, risks and design decisions
Strengthens your Design History File and Technical Documentation
Helps avoid late-stage regulatory issues or costly test repetitions
Aligns Human Factors with risk management and clinical evidence
Why Regulatory Support is Essential for Human Factors Compliance
Human Factors and Usability are core components of medical device regulations across global markets. IEC 62366-1 and its practical guidance IEC 62366-2 require a structured process for identifying, evaluating and mitigating use-related risks throughout development. In parallel, the MDR/IVDR demand clear evidence that the product can be used safely and effectively by the intended users under real-use conditions. The FDA requires Human Factors Validation for most high-risk medical devices. Without properly planned and documented usability work, approval delays, rejections or recalls become real risks.
Fulfills IEC 62366-1, ISO 14971, MDR/IVDR, FDA and NMPA requirements
Enables traceability of user needs, risks and design decisions
Strengthens your Design History File and Technical Documentation
Helps avoid late-stage regulatory issues or costly test repetitions
Aligns Human Factors with risk management and clinical evidence