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

21 CFR (Code of Federal Regulations) Part 820 related discussions.

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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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657
Marcelo Antunes
E
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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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26,224
somashekar
kingkobra
Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
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6
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4,757
Julie O
Marc
  • Sticky
ISO 13485, ISO 14971 and other Medical Device Related Forums
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0
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7,614
Marc
Ajit Basrur
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  • Sticky
21 CFR Part 820 - QUALITY SYSTEM REGULATION
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0
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11,686
Ajit Basrur
Forum Discussion Threads
J
Steps when changing material for class 1 medical device
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1
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62
chris1price
Q
Release of the first batch of a cleared product before process validation
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4
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143
planB
A
Determining Sample Size in Design V&V activities
2 3 4
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32
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8,246
anpun
S
When medical devices are sold domestically, can they be sold in Puerto Rico?
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2
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132
supadrai
S
'Beta testing' & Design Controls
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6
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137
shimonv
E
Declarations of conformity and summary reports
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5
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4,404
Lilla
W
ERP Audit Trail audit by FDA? Regular audit trail report template?
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9
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140
Wolf.K
T
Misbranding (by someone we've contracted with) in a Publication
2
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15
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971
tebusse
L
Traditional 510(K) - Software - Clinical testing?
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1
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88
yodon
Ajit Basrur
Looking for a Design Transfer Checklist
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1
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232
yodon
temujin
Change of Existing Medical Devices and 510(k) - "Letter to File" and "Add to File"
2 3 4
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37
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33,589
robert.beck
S
Is Certificate of Conformance required for an OEM released product?
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0
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76
SGquality
A
List of FDA recognized standards for medical devices
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4
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1,583
planB
S
Is Human Factor Testing required as part of Design Control Validation?
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3
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144
yodon
S
In a risk analysis, how can we tie mobile app security breach to ISO 14971?
Replies
3
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126
Mark Meer
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