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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
US Medical Device Regulations
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21 CFR Part 820 - US FDA Quality System Regulations (QSR)
21 CFR (Code of Federal Regulations) Part 820 related discussions.
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E
Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)?
eddieuk
Feb 23, 2021
2
Replies
10
Views
4K
Sep 20, 2023
CDCCarmela
C
A
Pre-Sub Meeting
Allie
Sep 19, 2023
Replies
6
Views
345
Sep 19, 2023
Ed Panek
A
Registration requirements for custom branded device
anonymous_wantrepreneur
Nov 9, 2020
2
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10
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2K
Sep 5, 2023
XRAY_3121
I
Product Lifetime on Labeling
itsasupernova
Aug 18, 2023
Replies
1
Views
256
Aug 18, 2023
EmiliaBedelia
E
Statistics Question
Ed Panek
Aug 3, 2023
Replies
4
Views
387
Aug 18, 2023
Steve D
S
Q
510k for Exempt Class I Medical Device - Industry Advantage to having a 510k Approval
Quality96 - 2011
May 14, 2009
2
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13
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8K
Aug 18, 2023
JT Tung
J
C
Required Designated Roles - 21 CFR 820
Chani
Jul 26, 2023
Replies
3
Views
348
Jul 26, 2023
Ed Panek
B
Medwatch - Manufacture Reference # AKA Complaint #
BLSBoyd
Jul 18, 2023
Replies
1
Views
248
Jul 18, 2023
Tidge
T
J
Establishment registration FDA 'Foreign exporter'
JimBa
Apr 14, 2014
Replies
5
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6K
Jul 17, 2023
MJW66
M
A
21CFR807.25 (d) Owner-Operator Contact question
ajbera3
Jan 28, 2015
Replies
2
Views
2K
Jul 13, 2023
Highground
B
Gamma Irradiation - Multiple doses to achieve the Dose range
Balachander
May 16, 2023
Replies
1
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266
Jul 6, 2023
planB
D
Rx only symbol on Drapes
destroyed9218
Jun 8, 2023
Replies
2
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196
Jun 28, 2023
LUFAN
L
Independent Reviewer - Design Controls
Ajit Basrur
Jun 23, 2023
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4
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302
Jun 25, 2023
Ampein
A
D
Supplier-questionable GDP method
donna0816
Jun 16, 2023
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1
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262
Jun 19, 2023
yodon
Y
C
TMV Report Protocols
cunshan.yan888
Jun 7, 2023
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0
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245
Jun 7, 2023
cunshan.yan888
C
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Medical Device Related Regulations
US Medical Device Regulations
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