Other US Medical Device Regulations

Other applicable regulations and topics related to United States medical devices and manufacturers.
S
Differentiate between Critical and High risk vendors
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3
Views
256
yodon
Y
R
Addressing training requirements - 21 CFR Part 820.25 (1) & (2)
Replies
6
Views
3K
RCW
R
N
Regulations for Medical Device in Jamaica
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0
Views
247
NJoyRegButNeedHelp
N
S
Certificates to Foreign Governments (CFG) foreign manufacturer
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0
Views
273
SteTop
S
I
21 CFR 806 Corrections and Removals
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4
Views
691
indubioush
I
U
Does Medical Device training video falls under labeling requirement ?
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4
Views
429
Ed Panek
Ed Panek
D
Initial Importer question
Replies
2
Views
547
Orca1
Orca1
M
CBE (Change Being Effected) 510(k) Submission
Replies
9
Views
5K
Orca1
Orca1
J
ASTM F965 Laryngoscopes
Replies
1
Views
257
Sidney Vianna
Sidney Vianna
D
CFG application issues
Replies
0
Views
335
danir30
D
P
AIM 7351731 RFID reader immunity
Replies
5
Views
2K
Highground
Highground
C
Data Matrix and DPM (direct part marking) UDI Standards - ISO/IEC TR 29158
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3
Views
3K
newtoquality
N
T
FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device
2
Replies
13
Views
2K
TomQA
T
N
UDI for OTS Components
Replies
1
Views
508
yodon
Y
N
Can we take a part from 510k cleared medical device and use it in class I device?
Replies
6
Views
1K
Ronen E
Ronen E
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