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2023年中国药监局NMPA蓝皮书已发布:

Usability/Human Factors Study: Understanding the Requirements in China and the U.S

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  • 创建日期 4 9 月, 2024
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Usability/Human Factors Study: Understanding the Requirements in China and the U.S

The role of usability and human factors in medical devices has become globally important across most of the key countries. In this session, we will focus on US and China to review the human factors extending beyond design and into registration and post-market phases. Join us for a comprehensive webinar that explores this crucial topic, focusing on the unique landscapes of China and the United States.

  • The Global Rising Importance : An introduction to why usability and human factors have become integral in medical device lifecycle.
  • Regulatory Insights: A comparative study of the regulatory guidelines in China and the U.S., highlighting the common and different requirements
  • Key Steps of Human Factor Studies & Design Strategies: how to design and implement the human factor studies
  • Real-world Examples & Best Practices

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