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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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Finding Medical Device Listing Numbers on the USA's FDA site
Exact
Dec 3, 2009
2
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19
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34,259
Mar 28, 2019
Ronen E
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FDA plans to use ISO 13485 for Medical Devices Regulation
Sidney Vianna
Aug 30, 2018
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8
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1,685
Aug 31, 2018
Marcelo
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Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
kingkobra
Sep 25, 2013
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5,250
Oct 24, 2016
Julie O
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ISO 13485, ISO 14971 and other Medical Device Related Forums
Marc
Oct 18, 2009
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8,092
Oct 18, 2009
Marc
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21 CFR Part 820 - QUALITY SYSTEM REGULATION
Ajit Basrur
Apr 22, 2008
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12,683
Apr 22, 2008
Ajit Basrur
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Retrospective Validation - Class I device
yWOrcons
Tuesday at 1:36 PM
2
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10
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122
Yesterday at 10:08 PM
Watchcat
Q
Must product name be listed the same name in FURLS, UDI, GUDID and Company Website?
QualityDean
Mar 16, 2020
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64
Mar 16, 2020
Ronen E
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510(K) File eCopy Submission
Kuldeep Singh
Jan 23, 2020
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6
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175
Mar 12, 2020
monoj mon
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Devices from IQ, OQ or PQ process to be used for verification, validation and summative?
Given2Fly
Feb 23, 2020
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5
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384
Mar 9, 2020
indubioush
Q
Relabeler for patent expired product - design control responsibilities?
QualityDean
Mar 2, 2020
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2
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126
Mar 2, 2020
pziemlewicz
V
Writing a Pre-Submission to the FDA
venezia
Jan 9, 2017
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39
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7,540
Feb 26, 2020
Watchcat
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Labeling for Medical Device Samples - Surgical instruments
zeypzeyn
Feb 24, 2020
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3
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124
Feb 25, 2020
shimonv
Q
LOT or Serial Number Symbol not used when the information is contained in the UDI?
QARA93
Feb 20, 2020
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91
Feb 20, 2020
shimonv
C
Medical Device Shelf life studies
Chef100
Feb 14, 2020
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167
Feb 16, 2020
Watchcat
21 CFR Part 820 - FDA Label Requirements
Ed Panek
Jan 3, 2020
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8
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342
Feb 14, 2020
DonkeyKang
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Non conformance product identification and traceability
Torrito20
Feb 13, 2020
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178
Feb 14, 2020
Marc
S
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Is any dissatisfaction over a Medical Device considered as a complaint?
SGquality
Feb 5, 2020
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185
Feb 13, 2020
Ajit Basrur
S
What is a "Device Malfunction" for MDR purposes?
suffusive
Feb 13, 2020
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1
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88
Feb 13, 2020
shimonv
A
UDI and Design Controls - Labeling change via the Design Control process
ASteel
Feb 6, 2020
Replies
1
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129
Feb 6, 2020
pziemlewicz
S
What is the significance of UDI date requirements for Class 1 devices?
SGquality
Sep 19, 2018
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4
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583
Feb 5, 2020
Ronen E
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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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