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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
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Medical Device and FDA Regulations and Standards News
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IVD Device Design Change
mflick22
Mar 6, 2023
Replies
7
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729
May 7, 2024
Parul Chansoria
Medical Device News
Proper Spanish translation
Ed Panek
Apr 19, 2024
Replies
0
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220
Apr 19, 2024
Ed Panek
Q
MDD devices from class I
Qualiana
Apr 19, 2024
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0
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108
Apr 19, 2024
Qualiana
Q
E
Non-destructive inspection of PS tray-tyvek welding process
erdal88
Mar 25, 2024
Replies
4
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291
Apr 18, 2024
Hendi
H
C
EO Residual testing
CCurran
Apr 14, 2024
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5
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198
Apr 18, 2024
planB
A
Changing Manufacturer due to Spin Off
afakhraee
Feb 29, 2024
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3
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692
Apr 2, 2024
indubioush
I
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Verification vs Validation of off site cnc machining for parts of medical device
JPhillips
Mar 28, 2024
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1
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264
Mar 29, 2024
yodon
Y
D
Prop 65 labeling
destroyed9218
Mar 27, 2024
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3
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207
Mar 27, 2024
Randy
T
US FDA Electronic Patient Implant Card
ttrinh3342
Mar 22, 2024
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2
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184
Mar 22, 2024
yodon
Y
U
GCP Computerized Systems
urvikraj
Mar 20, 2024
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225
Mar 20, 2024
yodon
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P
FDA Vendor Day
PharmaBro
Mar 11, 2024
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380
Mar 11, 2024
PharmaBro
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B
510(k) eStar Template Problem
B-Kabitz
Feb 26, 2024
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317
Feb 29, 2024
Sicco
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Notify Competent authorities per Article 83 point 4 for PMS related CAPAs
bimeri
Feb 28, 2024
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3
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294
Feb 28, 2024
yodon
Y
N
Health Canada submission
navdeep
Feb 21, 2024
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263
Feb 26, 2024
navdeep
N
K
FDA Registration and listing weird situation
katastic2908
May 24, 2021
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1K
Feb 23, 2024
Haresh
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