21 CFR Part 820 - US FDA Quality System Regulations (QSR)

21 CFR (Code of Federal Regulations) Part 820 related discussions.
FAQs
Sidney Vianna
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FDA plans to use ISO 13485 for Medical Devices Regulation
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13
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5K
bkelly79
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Finding Medical Device Listing Numbers on the USA's FDA site
2
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19
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50K
Ronen E
Ronen E
K
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Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
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6
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7K
Julie O
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Marc
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ISO 13485, ISO 14971 and other Medical Device Related Forums
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0
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9K
Marc
Marc
Ajit Basrur
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  • Sticky
21 CFR Part 820 - QUALITY SYSTEM REGULATION
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0
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14K
Ajit Basrur
Ajit Basrur
Discussions
S
Annual Product Review required for Medical Device (21CFRpart 820)?
2
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12
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167
yodon
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M
Is Bio-C testing required for a second supplier of injection moulded parts?
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2
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149
planB
planB
FRA 2 FDA
Mock FDA Inspection
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7
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145
Ed Panek
Ed Panek
P
What am I? Specification Developer or R&D Firm?
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8
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3K
Haresh
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Device Labeling "Manufactured for"
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21
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20K
Haresh
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Extent of What is Considered a Design Change (820.30i)
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7
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316
Ed Panek
Ed Panek
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Are Design History Files required by "Product Labelers" in order to ship in the USA?
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1
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236
William55401
William55401
D
QMSR and MDSAP
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7
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573
dr1vn
D
Darrin Carlson
QMSR Problems?
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5
Views
529
Weeder
W
nehalmahajan55
Device Master Record
Replies
2
Views
309
Ed Panek
Ed Panek
nehalmahajan55
Design History Record (DHR) Format
Replies
6
Views
480
Ed Panek
Ed Panek
nehalmahajan55
Design History File - Design Input
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0
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311
nehalmahajan55
nehalmahajan55
J
Import to Export question
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1
Views
309
Parul Chansoria
Parul Chansoria
Z
Labeling for Medical Device Samples - Surgical instruments
Replies
7
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3K
Ed Panek
Ed Panek
J
Labeling – potential field action?
Replies
5
Views
373
yodon
Y
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