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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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US Medical Device Regulations
United States Medical Device Regulations
21 CFR Part 820 - US FDA Quality System Regulations (QSR)
21 CFR (Code of Federal Regulations) Part 820 related discussions.
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1.5K
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9.2K
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L
QMSR Problems?
Friday at 12:58 PM
LUFAN
Other US Medical Device Regulations
Other applicable regulations and topics related to United States medical devices and manufacturers.
Threads
729
Posts
3.8K
Threads
729
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3.8K
E
Re-importing exported medical devices into the US
Jan 31, 2024
ERM-Reg
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J
Class I Exempt FDA Question
jbm12
Feb 13, 2024
Replies
2
Views
175
Friday at 1:15 PM
jbm12
J
R
Selling same device as IVD and RUO
REG12
Feb 20, 2023
2
Replies
10
Views
707
Mar 11, 2024
akp060
A
UDI Management
Ed Panek
Mar 5, 2024
Replies
1
Views
101
Mar 5, 2024
LUFAN
L
E
Why a 510k can includes multiple medical devices with difference indication for use
Emma2010
Dec 14, 2023
Replies
7
Views
640
Mar 4, 2024
Emma2010
E
L
Complaint Handling Under QMSR
LUFAN
Jan 31, 2024
2
Replies
12
Views
526
Mar 4, 2024
Chrisx
C
C
QMSR changes to inspection of records
Chrisx
Feb 28, 2024
Replies
1
Views
139
Feb 28, 2024
LUFAN
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L
Letter to File
LTran
Feb 16, 2024
Replies
0
Views
149
Feb 16, 2024
LTran
L
B
Private Labeling a Class II device to be used with our device
B-Kabitz
Feb 7, 2024
Replies
2
Views
145
Feb 13, 2024
B-Kabitz
B
FDA and ISO 13485 News
Ed Panek
Dec 8, 2023
Replies
7
Views
571
Feb 1, 2024
LUFAN
L
Foreign Language Label
Ed Panek
Jan 25, 2024
Replies
1
Views
185
Jan 25, 2024
DallasThomasIQVIA
Using an old predicate
shimonv
Jan 16, 2024
Replies
8
Views
352
Jan 24, 2024
EmiliaBedelia
E
Package Inserts for Single Packed Implantable
austin_howell
Jan 16, 2024
Replies
3
Views
169
Jan 24, 2024
indubioush
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FDA 510(k)
nthangcnhh
Jan 18, 2024
Replies
1
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169
Jan 24, 2024
indubioush
I
E
Lurking manufacturer responsibilities relating to user error & informing other manufacturers
Errek
Jan 12, 2024
Replies
3
Views
209
Jan 17, 2024
Tidge
T
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Does Initial Importer need to audit the Exporter?
Nancylove
Dec 29, 2023
Replies
1
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236
Dec 29, 2023
shimonv
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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