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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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EU Medical Device Regulations
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
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M
CE Mark Medical Devices - Annexes II, IV, V and VI
M & M
Dec 8, 2004
Replies
4
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3K
Dec 9, 2004
Al Rosen
F
What's the gap between CE-marking and FDA's approval?
Fahle
Aug 6, 2004
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1
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4K
Aug 6, 2004
Kevin Mader
H
Is ISO 13485:2003 Certification neccessary to get the CE Mark?
Hello - 2006
Nov 6, 2003
2
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16
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8K
Dec 18, 2003
Vincnet
V
N
CE Mark Auditing - All they had for CE was a written Technical Justification
nancyi
Jun 5, 2002
Replies
5
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3K
Jun 5, 2002
nancyi
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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