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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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Other US Medical Device Regulations
Other applicable regulations and topics related to United States medical devices and manufacturers.
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D
Project Planning Approval Board Approval signatures - FDA regulated medical device
danpa
Apr 18, 2009
Replies
1
Views
3K
Apr 18, 2009
MIREGMGR
M
O
DHF (Design History File) Template
oldlady
Apr 6, 2009
2
Replies
13
Views
18K
Apr 15, 2009
Al Rosen
M
List of FDA Required Procedures
maxwell
Mar 18, 2009
Replies
5
Views
4K
Apr 14, 2009
Chris Ford
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L
FDA CAPA Requirement for Contract Med. Dev. Manufacturers
LNeJame
Apr 2, 2009
Replies
4
Views
3K
Apr 2, 2009
gar4guv
G
A
FDA Regulation Training Materials
achenry
Nov 20, 2008
Replies
5
Views
4K
Mar 19, 2009
Al Rosen
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Can we use the data in intertek or TUV lab testing report as bench testing data?
luloo117117
Mar 17, 2009
Replies
2
Views
4K
Mar 18, 2009
luloo117117
L
H
Working from a previous design history. How can I best leverage the exisitng DHF?
HighRisk
Mar 16, 2009
Replies
4
Views
2K
Mar 18, 2009
HighRisk
H
Format to log complaints per FDA sec. 820.198
somashekar
Mar 9, 2009
Replies
7
Views
7K
Mar 17, 2009
Al Rosen
B
What happened to Part 804? 820.198 (3) references part 803 or 804
bigup1ca
Feb 19, 2009
Replies
4
Views
7K
Feb 19, 2009
MIREGMGR
M
510(k) filing for GSM (Global System for Mobile Communication) technology?
kisxena
Dec 22, 2008
Replies
9
Views
4K
Jan 3, 2009
venkatesan
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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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