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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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FDA Vendor Day
PharmaBro
Mar 11, 2024
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229
Mar 11, 2024
PharmaBro
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A
Changing Manufacturer due to Spin Off
afakhraee
Feb 29, 2024
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438
Feb 29, 2024
afakhraee
A
B
510(k) eStar Template Problem
B-Kabitz
Feb 26, 2024
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1
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178
Feb 29, 2024
Sicco
S
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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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140
Feb 28, 2024
yodon
Y
N
Health Canada submission
navdeep
Feb 21, 2024
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145
Feb 26, 2024
navdeep
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K
FDA Registration and listing weird situation
katastic2908
May 24, 2021
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1K
Feb 23, 2024
Haresh
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NRTL Certification for US
bethfulcher
Feb 19, 2024
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159
Feb 19, 2024
bethfulcher
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A
ISO13485 7.2.1 (d) User Training
April H
Oct 18, 2023
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3
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711
Feb 3, 2024
DanMann
D
H
Does a PLC (programmable logic controller) as a component of a medical device need software validation?
helles
Jan 23, 2024
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6
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465
Feb 1, 2024
helles
H
I
FDA Quality System Regulation Amendments
indubioush
Feb 1, 2024
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186
Feb 1, 2024
indubioush
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US FDA 510k Clearance Complete!!!! Africa???
Mangafanga
Jan 20, 2024
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357
Jan 31, 2024
kjlcm
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Establishment Registration and Device listing - Wording of 807.20 (a) (6)
Putnam
Apr 27, 2020
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2K
Jan 31, 2024
Haresh
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Electronic QMS Validation?
bolesen
Jan 8, 2024
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381
Jan 22, 2024
Enternationalist
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Transition period for manufacturers to adopt new versions of medical device standards - IMDRF
Gledy Martinez
Jan 12, 2024
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390
Jan 16, 2024
planB
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UDI requirements on packaging
NMA27
Dec 26, 2023
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490
Jan 5, 2024
yodon
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