

Common QMS Mistakes SaMD Companies Make
Oct 21, 2022
Chapters
Transcript
Episode notes
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
Introduction
00:00 • 2min
What Is a Quality Management System?
02:08 • 2min
What Is a Quality Management System?
04:06 • 2min
What Does Software Validation Mean?
06:21 • 2min
What Kind of Validation Do You Need to Validate?
07:52 • 2min
Validating the Elements of a Quality Management System?
09:50 • 2min
Validating Quality Training Programs
12:03 • 2min
SamD
13:55 • 3min
What Are Your Thoughts About the Apple Watch?
16:57 • 2min
How Does That Fit Into Your Quality Management System?
18:29 • 2min
Is Your Quality Management System a Software or a Physical?
20:45 • 2min
Machine Learning Versus AI as a Medical Device
22:47 • 2min
Bringing It Back to the Designed Use Statement
24:47 • 2min
What Kind of Perspective Should You Have When Looking at Suppliers?
26:38 • 2min
What Is the Risk Based Approach to Quality Management?
28:12 • 2min
Is There a Difference Between a-Lop and as Far as Possible?
30:09 • 2min
Is It Possible to Have a Design Reviewer Perform the Design Review?
32:34 • 2min
Is ISO 13485 Specification Different From En?
34:58 • 3min
EU MDR or MDD? What's the Difference?
38:00 • 3min
How to Deal With an Unannounced Audit
40:33 • 2min
How to Build a Quality Management System in Your Company
42:14 • 2min
Global Medical Device Podcast - Greenlight Guru
44:10 • 2min