Ep 2 Series 11 | Understanding FDA Perspectives on Medical Device Development
FEB 12, 202412 MIN
Ep 2 Series 11 | Understanding FDA Perspectives on Medical Device Development
FEB 12, 202412 MIN
Description
In this episode, titled "Understanding FDA Perspectives on Medical Device Development" we embark on a comprehensive exploration of FDA perspectives alongside Greg Montalbano, Co-Founder of MIDI.
Greg takes us on a comprehensive journey through FDA perspectives on Human Factors and Device Development, covering essential topics such as:
- The FDA's concern regarding Human Factors Engineering and Usability
- Expectations for medical device developers from the FDA
- Real-world examples of medical device Human Factors Engineering relative to hazards, risks, and user-related causes
This episode provides listeners with invaluable insights into the significance placed by both the FDA and MIDI on Usability Research and HFE quality processes. By understanding these crucial aspects, developers can ensure the creation of safe and effective medical devices that align with regulatory standards.
Listen to MIDI’s HFE MedTech Podcast Episode 2!
Don't miss out on this enlightening discussion—tune in now to gain a comprehensive understanding of FDA perspectives and the importance of Usability Research in medical device development!
