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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
US Medical Device Regulations
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21 CFR Part 820 - US FDA Quality System Regulations (QSR)
21 CFR (Code of Federal Regulations) Part 820 related discussions.
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S
Device Master Records for a Contract Manufacturer
SGquality
May 19, 2015
Replies
4
Views
4K
May 19, 2015
SGquality
S
A
Training material for interpretation & understanding Part 11 requirements
Aphel
May 13, 2015
Replies
2
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2K
May 16, 2015
Aphel
A
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FDA Medical Device Registration - Scenario - Two Companies
IDENT12345
May 11, 2015
Replies
4
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2K
May 12, 2015
Sarah Stec
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A
Medical Device Handling AFTER the device's specified lifetime has expired
Aphel
May 11, 2015
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2
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2K
May 11, 2015
Ronen E
A
US patient gets Medical Device in Europe and needs spare parts
Aphel
May 8, 2015
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2
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2K
May 8, 2015
Ronen E
Q
Is Medical Device 510(k) exempt or not really exempt?
QACen
Feb 20, 2015
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2
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2K
May 8, 2015
mihzago
A
Timeframe for Product Label Update after Company Name Change
ajbera3
May 6, 2015
Replies
3
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2K
May 7, 2015
MIREGMGR
M
J
Minimum staff per 21 CFR Part 820
Jennifer27
May 6, 2015
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2
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2K
May 6, 2015
phoenix2368
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4
Customer Making Changes to a 510k Device They Purchased
4810RAJ
May 5, 2015
Replies
1
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2K
May 5, 2015
Ronen E
C
Advise on Oral Spray Pad Printing and Compliance
Chintan.shah
Apr 20, 2015
Replies
2
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2K
May 2, 2015
Ronen E
D
User Requirements Tracing - Verification and Validation Requirements
dwayneq
Apr 30, 2015
Replies
1
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2K
Apr 30, 2015
Ronen E
K
What technical documents need to be maintained for "manufactured for" items
KeithDMedi
Apr 28, 2015
Replies
8
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3K
Apr 29, 2015
MIREGMGR
M
Q
Internal Program audit Scope for NPI
QAengineer13
Apr 28, 2015
Replies
1
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2K
Apr 29, 2015
lk2012
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Is there any difference between QUALITY SYSTEM RECORD & QUALITY MANUAL
somnathzambare
Apr 29, 2015
Replies
1
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3K
Apr 29, 2015
John Broomfield
R
Is it a requirement to notify my customer if I receive a 483 from the FDA?
RCW
Apr 24, 2015
Replies
6
Views
2K
Apr 24, 2015
Ronen E
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
US Medical Device Regulations
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