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

21 CFR (Code of Federal Regulations) Part 820 related discussions.
FAQs
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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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29,199
Ronen E
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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1,188
Marcelo Antunes
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Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
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6
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4,978
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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7,815
Marc
Ajit Basrur
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21 CFR Part 820 - QUALITY SYSTEM REGULATION
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0
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11,995
Ajit Basrur
Discussions
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Loss of a Quality Record - FDA Inspection
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N/A
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Handling open points in design reviews
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4
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163
yodon
S
Sterilization Site Move - Dec 2018 FDA Guidance Document
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1
Views
67
shimonv
J
UDI Requirements - Products that all fall under the same family
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3
Views
146
jkc3usc
S
Medical Device Initial Importer (DII) Requirements - Delivery Address
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0
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96
SGquality
S
Which department manages Establishment Registration, Device Listing and GUDID?
Replies
1
Views
69
craiglab
C
Labeling and UDI requirements for medical device kits
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5
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1,397
RL-WANG
S
Understanding UDI requirements - Class 2 medical device (hearing aids)
Replies
3
Views
272
RL-WANG
S
AA or AAA batteries a medical device?
Replies
7
Views
2,046
amitkbme
K
Distribution medical devices to US Embassies
Replies
2
Views
168
keldez
Ed Panek
Splitting UI (User Interface) into two development paths
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4
Views
110
Ed Panek
S
Bringing a Medical Device Sample from a Foreign Country into the US
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6
Views
2,814
Kathy Moon
Q
Device History Records Maintenance - Discontinued the use of the Product
Replies
5
Views
1,685
burkyle
Ajit Basrur
Requirements for Refurbishment of Medical Devices in Mexico
2
Replies
10
Views
301
Genaro Luevano
E
Declarations of conformity and summary reports
Replies
7
Views
4,999
Pads38
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