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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
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13
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5K
Sep 14, 2020
bkelly79
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Sticky
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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49K
Mar 28, 2019
Ronen E
K
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Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
kingkobra
Sep 25, 2013
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6
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7K
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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Oct 18, 2009
Marc
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21 CFR Part 820 - QUALITY SYSTEM REGULATION
Ajit Basrur
Apr 22, 2008
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14K
Apr 22, 2008
Ajit Basrur
Discussions
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Labeling for Medical Device Samples - Surgical instruments
zeypzeyn
Feb 24, 2020
Replies
7
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3K
Apr 15, 2024
Ed Panek
QMSR Problems?
Darrin Carlson
Mar 4, 2024
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4
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263
Apr 12, 2024
FRA 2 FDA
J
Labeling – potential field action?
Jkc3usc12
Mar 21, 2024
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5
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197
Mar 29, 2024
yodon
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Change to an FDA Cleared Device
RamsayP
Jan 24, 2024
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4
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300
Mar 23, 2024
Haresh
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Convenience Kits-Not for Human Use
Maryvicki
Mar 5, 2024
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5
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290
Mar 11, 2024
Maryvicki
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What does "fully verify" mean exactly in process validation?
terrytw
Apr 17, 2023
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9
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962
Mar 1, 2024
propdto
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Import to Export question
Jkc3usc12
Feb 14, 2024
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122
Feb 14, 2024
Jkc3usc12
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QMSR and MDSAP
dr1vn
Feb 9, 2024
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250
Feb 12, 2024
Tidge
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DHR Records
Mindy Robinson
Dec 11, 2023
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1
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167
Dec 11, 2023
Ed Panek
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Medical Device Contract Manufacturer - Does the CM need to register with FDA?
Aramac
Feb 23, 2021
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2K
Dec 7, 2023
Haresh
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How do I show compliance to 21CFR820?
Mangafanga
Nov 17, 2023
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235
Nov 17, 2023
Ed Panek
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Use of Loaners for MEE while devices are serviced
dartmccart
Jul 23, 2020
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635
Oct 19, 2023
Edgar Trejo
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US Manufacturer of Export Only Exempt Products applying for CFG
jerryz
Jul 16, 2019
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1K
Oct 13, 2023
Emma2010
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Bioburden and Endotoxin (LAL) Testing proposal help
IHaveNoSpaceBar
Oct 8, 2012
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6
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7K
Oct 12, 2023
planB
H
How to register my establishment and appropriate labeling
helenaonFDAadventure
Sep 28, 2023
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3
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326
Oct 4, 2023
EmiliaBedelia
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
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US Medical Device Regulations
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