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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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FAQs
Sticky
FDA plans to use ISO 13485 for Medical Devices Regulation
Sidney Vianna
Aug 30, 2018
Replies
8
Views
864
Aug 31, 2018
Marcelo Antunes
E
Sticky
Finding Medical Device Listing Numbers on the USA's FDA site
Exact
Dec 3, 2009
2
Replies
10
Views
27,171
Feb 10, 2017
somashekar
K
Sticky
Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
kingkobra
Sep 25, 2013
Replies
6
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4,838
Oct 24, 2016
Julie O
Sticky
ISO 13485, ISO 14971 and other Medical Device Related Forums
Marc
Oct 18, 2009
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0
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7,686
Oct 18, 2009
Marc
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21 CFR Part 820 - QUALITY SYSTEM REGULATION
Ajit Basrur
Apr 22, 2008
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11,782
Apr 22, 2008
Ajit Basrur
Discussions
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Submission or Letter to file?
Timothea
15 minutes ago
Replies
0
Views
1
15 minutes ago
Timothea
I
Bench Testing & Pre-verification vs. Formal verification
Inclag
Yesterday at 10:48 AM
Replies
0
Views
22
Yesterday at 10:48 AM
Inclag
P
510(k) cleared, Rx only and home use
PearlKetchup
Feb 7, 2019
Replies
6
Views
147
Friday at 3:05 PM
PearlKetchup
K
Relabeling or Not Relabeling - Adding our internal Part Number barcode label
kellascat
Feb 7, 2019
Replies
1
Views
71
Feb 12, 2019
Marc
S
UDI (Unique Device Identification) Requirements for Remanufactured devices
SGquality
Feb 10, 2019
Replies
1
Views
58
Feb 12, 2019
Marc
S
Looking for procedure on UDI (Unique Device Identification)
SGquality
Feb 11, 2019
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0
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53
Feb 11, 2019
SGquality
D
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FDA QSR task checklist based on inspection citations
Darshan_Shetty
Feb 3, 2019
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5
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118
Feb 6, 2019
Darshan_Shetty
D
Used active medical devices
Developer_Germany
Aug 23, 2018
Replies
4
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349
Feb 6, 2019
LostLouie
C
Labeling and UDI requirements for medical device kits
celticfrosting
Feb 8, 2018
Replies
3
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1,010
Jan 31, 2019
UDIPadawan
T
Executive summary for Traditional 510(k)
Timothea
Jan 31, 2019
Replies
2
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85
Jan 31, 2019
Timothea
S
Understanding UDI requirements - Class 2 medical device (hearing aids)
SGquality
Jan 23, 2019
Replies
2
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128
Jan 24, 2019
SGquality
V
Writing a Pre-Submission to the FDA
venezia
Jan 9, 2017
2
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16
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4,139
Jan 24, 2019
Dobby1979
S
FDA Inspections and Pest Control - Pallets too close to walls
Schkund
Jan 4, 2019
2
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15
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431
Jan 23, 2019
Idjits.ix
A
Determining Sample Size in Design V&V activities
Aphel
Nov 10, 2012
2
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5
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40
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9,262
Jan 22, 2019
Statistical Steven
J
Definition of repackager v. manufacturer
joemar
Jan 15, 2019
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0
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63
Jan 15, 2019
joemar
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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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