In this episode, “Understanding FDA Perspectives on Medical Device Development,” we explore and in-depth review with Greg Montalbano, Co-Founder of MIDI. Greg offers valuable insights into the FDA’s viewpoints on human factors and device development. 

Key Podcast Topics Include:

• Human Factors Engineering and Usability: Explore the FDA’s concerns and guidelines.
• Developer Expectations: Learn what the FDA expects from medical device developers.
• Practical Examples: Understand how Human Factors Engineering impacts real-world device hazards, risks, and user interactions.

Gain a deeper understanding of the importance of usability research and quality processes in Human Factors Engineering, and how they align with FDA standards to ensure the safety and effectiveness of medical devices.