In this episode, “Human Factors Regulatory & Guidance Standards for US Submission,” we delve into the essential organizations, regulatory bodies, and standards crucial for conducting usability research and implementing human factors engineering in medical device design and development.

Key Podcast Topics Include:

• U.S. Regulatory and Guidance Documents: Explore the key organizations issuing guidance for human factors in medical device development.
• Applicable Standards and Guidelines: Understand the U.S. standards and guidelines relevant to different types of medical devices.
• International Regulatory Standards: Learn about global human factors standards recognized by the FDA and AAMI, and their importance in medical device regulation.

Explore this episode to deepen your insight into the key principles and practices of human factors engineering, contributing to innovation and enhanced patient care.