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Common QMS Mistakes SaMD Companies Make

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