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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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FDA plans to use ISO 13485 for Medical Devices Regulation
Sidney Vianna
Aug 30, 2018
2
Replies
13
Views
2,643
Sep 14, 2020
bkelly79
E
Sticky
Finding Medical Device Listing Numbers on the USA's FDA site
Exact
Dec 3, 2009
2
Replies
19
Views
39,937
Mar 28, 2019
Ronen E
K
Sticky
Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
kingkobra
Sep 25, 2013
Replies
6
Views
5,482
Oct 24, 2016
Julie O
Sticky
ISO 13485, ISO 14971 and other Medical Device Related Forums
Marc
Oct 18, 2009
Replies
0
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8,330
Oct 18, 2009
Marc
Locked
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21 CFR Part 820 - QUALITY SYSTEM REGULATION
Ajit Basrur
Apr 22, 2008
Replies
0
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13,042
Apr 22, 2008
Ajit Basrur
Discussions
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21 CFR 820.20 - Quality Planning Requirements?
twiztedwallaby
Tuesday at 2:34 PM
Replies
2
Views
73
Tuesday at 5:33 PM
Ajit Basrur
C
Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size
cdmdux
Jan 4, 2021
2
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11
Views
275
Saturday at 6:53 AM
Bev D
R
What information do i need to get from the device manufacturer
rudra
Friday at 3:30 PM
Replies
0
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49
Friday at 3:30 PM
rudra
A
Registration requirements for custom branded device
anonymous_wantrepreneur
Nov 9, 2020
Replies
9
Views
257
Friday at 10:32 AM
gogreen
F
Mobile app regulations - Class II medical device
Frank Katarow
Jan 7, 2021
Replies
1
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89
Jan 13, 2021
indubioush
O
Importing a Medical Device into the US from abroad
Oslap
Jul 14, 2018
Replies
8
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1,251
Jan 7, 2021
Ajit Basrur
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Re-packager/Re-Labeler - FDA Registration question
znelson
Apr 24, 2015
2
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11
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4,677
Jan 7, 2021
paullarn
O
Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document?
outdoorsNW
Dec 18, 2020
Replies
0
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139
Dec 18, 2020
outdoorsNW
C
Does an accessory need an IFU if it use is discussed in the Parent device IFU?
ChrisW
Dec 17, 2020
Replies
5
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168
Dec 18, 2020
ChrisW
Validating Excel (XLS) formulas
Ed Panek
Dec 3, 2020
Replies
7
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398
Dec 9, 2020
Tidge
C
Scrapping on production floor - Setup parts
Chrisx
Dec 2, 2020
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4
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225
Dec 3, 2020
Ninja
J
Cochlear Implant Testing
jograha
Dec 1, 2020
Replies
2
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116
Dec 1, 2020
jograha
FDA requirements for Servicing and Refurbishment of Medical Devices
cscalise
Mar 25, 2015
2
3
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23
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9,892
Nov 27, 2020
Mark Meer
A
PMA Modifications
aloe55
Nov 20, 2020
Replies
2
Views
153
Nov 20, 2020
aloe55
Q
Private Labeler FURLS Responsibility-USA
QualityDean
Nov 17, 2020
Replies
2
Views
126
Nov 17, 2020
monoj mon
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
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