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
2
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13
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2,414
bkelly79
E
Finding Medical Device Listing Numbers on the USA's FDA site
2
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19
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38,707
Ronen E
K
Medical Application Classification in Controlled/Uncontrolled by Mobile App State.
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6
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5,421
Julie O
Marc
  • Sticky
ISO 13485, ISO 14971 and other Medical Device Related Forums
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0
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8,254
Marc
Ajit Basrur
  • Locked
  • Sticky
21 CFR Part 820 - QUALITY SYSTEM REGULATION
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0
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12,927
Ajit Basrur
Discussions
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Importing a Medical Device from abroad
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2
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970
gogreen
C
Medical Device cGMP Training Powerpoint Presentation - Request
Replies
9
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9,244
Tidge
M
FDA Wall Clearance Requirements For Warehouse
Replies
9
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8,549
Jemmitt
J
21 CFR 821 Medical Device Tracking Requirement
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2
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143
Jen
A
Can a US manufacturer put export only products on a CFG?
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1
Views
83
monoj mon
A
GUDID - Packaging Levels
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8
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299
monoj mon
S
New Foreign Exporter Looking
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0
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103
superstarexporter
P
Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment
Replies
7
Views
369
Tidge
J
Customer Complaint Response
Replies
3
Views
186
yodon
K
FDA 510k electrosurgery
Replies
0
Views
102
kolorado22
Stoic
Manual soldering processes - 100% verifiable, or always requiring validation?
2
Replies
15
Views
729
Tidge
D
Help on Medical Device Manufacturing - New Medical Device Company
Replies
5
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1,325
Debra
S
Can a Contract Manufacturer "release" product on behalf of client to the market?
Replies
4
Views
279
Edward Reesor
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Writing a Pre-Submission to the FDA
2 3 4 5
Replies
44
Views
9,637
chris1price
P
Unrealistic Packaging Validation Sample Size
2
Replies
13
Views
694
Ed Panek
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