

Everything you Need to Know about SaMD from an FDA Perspective
Mar 1, 2021
Chapters
Transcript
Episode notes
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Introduction
00:00 • 2min
SMD - What's It All About?
01:38 • 5min
Risks and Benefits of SAMD Outputs
06:11 • 2min
Is S-a-M-D a Medical Device?
08:27 • 3min
IMDRF - Software Risk Management
11:30 • 4min
What's the Risk of a Buffer Overrun in a Medical Device?
15:51 • 2min
What's Your Favorite Episode on Your YouTube Channel So Far?
17:44 • 3min
Greenlight Guru - MGQMS - Is a Medical Device Quality Management System?
20:25 • 4min
Is the Digital Health a Center of Excellence?
24:43 • 3min
Mobile Medical Applications
27:13 • 3min
Clinical Decision Support Software - FDA's Encouragement
30:27 • 4min
Using a Flow Chart for a Software as a Medical Device
34:40 • 3min
Do Your Homework Early in the Development of Your SAMD Software
37:38 • 4min
Pre Submissions
41:30 • 3min
The Global Medical Device Podcast
44:25 • 2min