Global Medical Device Podcast powered by Greenlight Guru

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

Mar 16, 2022
Ask episode
Chapters
Transcript
Episode notes
1
Introduction
00:00 • 3min
2
What's Newd Iting and Inequality Management System?
03:02 • 2min
3
I'm a Professional Biometical Engineer. I Read Standards That Make Absolutely NoSense
05:04 • 3min
4
The Quality Equivalent of Global Harmonization
07:45 • 2min
5
What's the Difference Between CSR and One Three Forty Five?
09:18 • 2min
6
Do We Need to Keep Making Changes?
11:02 • 2min
7
Good Regulation Is Timeless
12:44 • 2min
8
Is Quality a Function of Geography?
15:12 • 2min
9
Are You Compliant With With Eight 20?
17:37 • 2min
10
The Time to Transition?
19:56 • 2min
11
Are You Required to Have a 13 Forty Five Certificate?
22:12 • 2min
12
The Leap From C S Arto C Masar Should Not Be a Revolutionary Thing
23:50 • 4min
13
The Longer Pole in the Tent, Mike
28:08 • 2min
14
Are Medical Device Companies Getting the Voice in the ISO Standards?
30:00 • 2min
15
I S O 13 Forty Five Certifications Are Not Exempt From FTA Inspections
32:12 • 2min
16
You Don't Need a 13 Forty Five Certificate
33:51 • 2min
17
Do You Think We're Not Recognizing Md Sa Certifications?
35:28 • 2min
18
Global Harmonization
37:51 • 3min
19
Is It a Sanity Check?
40:28 • 2min
20
Is This a C S M R?
42:36 • 4min
21
The Advantage of Pre-Announced Inspections
46:09 • 3min