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

21 CFR (Code of Federal Regulations) Part 820 related discussions.
Forum FAQ Threads
Sidney Vianna
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FDA plans to use ISO 13485 for Medical Devices Regulation
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8
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441
Marcelo Antunes
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Finding Medical Device Listing Numbers on the USA's FDA site
2
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10
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25,494
somashekar
kingkobra
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Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
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6
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4,701
Julie O
Marc
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ISO 13485, ISO 14971 and other Medical Device Related Forums
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0
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7,532
Marc
Ajit Basrur
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21 CFR Part 820 - QUALITY SYSTEM REGULATION
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0
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11,586
Ajit Basrur
Forum Discussion Threads
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Effective Date on Documents
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8
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61
Ninja
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Auditing "process validation" process
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2
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115
yodon
I
Requirements for different Labeling Levels
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2
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95
debbier
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Site Move - Question about Updating Product Labels
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4
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189
buffer18
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DHR (Device History Record) for Medical Device Software
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7
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5,284
sarkalgud
S
What is the significance of UDI date requirements for Class 1 devices?
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1
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114
SGquality
K
UDI Labeling for Medical Device Samples
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2
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168
debbier
J
MDR reporting and CAPA thoughts? Classifying Complaints on Risk
2
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13
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378
tazer
J
Class 1 Medical Device ECR (Engineering Change Request) Changes
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4
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233
shimonv
R
How to keep track of all FDA rules and regulations for medical device companies
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2
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256
Emma_F
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