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

21 CFR (Code of Federal Regulations) Part 820 related discussions.
Ajit Basrur
Independent Reviewer - Design Controls
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4
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326
Ampein
A
D
Supplier-questionable GDP method
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1
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297
yodon
Y
C
TMV Report Protocols
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0
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276
cunshan.yan888
C
M
Importing a custom component for our medical device
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1
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310
Ed Panek
Ed Panek
D
FDA combo product-need to define direct & indirect impact regarding safety,quality & regulatory.Can anyone point me in right direction-SupplierMgmt
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0
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281
donna0816
D
T
Good Documentation Practices (GDocP) - Where are these described in the regulations?
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7
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1K
Ed Panek
Ed Panek
A
Medical Device DHF (Design History File) - One per Design Change?
2 3
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20
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9K
Susan826
S
T
Mandatory requirements for design verification sample
2
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11
Views
996
Chef100
C
I
Does being a subsidiary fully absolve company B from complying with 21 CFR 820?
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5
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3K
d_addams
D
D
Interpretation of 'Likely' in the reportability decision, specifically surgical delay.
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0
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299
d_addams
D
S
What is a "Device Malfunction" for MDR purposes?
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3
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1K
d_addams
D
R
Device History Record Title 21 CFR Part 820.184 (d) QSR
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3
Views
466
Reliable Source
R
B
Will FDA Inspect a New Coating Supplier for a Class III Combination Medical Device?
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2
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2K
praveensh
P
L
QMSR Final Rule On Track For December 2023
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0
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258
LUFAN
L
S
Is it possible to obtain FDA clearance (510k) without meeting QSR?
Replies
5
Views
589
Orca1
Orca1
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