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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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Discussions
Harmonised Standards on DoC (Declaration of Conformity)
rob73
Jun 14, 2012
Replies
8
Views
3,247
Jun 15, 2012
Pads38
T
Harmonized Standard Compliance Question
tebusse
Dec 6, 2012
Replies
5
Views
1,514
Dec 10, 2012
Ron Boumans
O
Harmonized standard of EU---EN 60601-2-10:2000/A1:2001
Onion_Mr
Mar 17, 2015
Replies
1
Views
1,032
Mar 18, 2015
Marcelo Antunes
M
Harmonized standards vs. EN ISO References
missjenny
Jun 27, 2016
Replies
5
Views
1,550
Jul 31, 2016
Ronen E
T
Has NB-MED 2.5.2-Rec 2 Version 8 been withdrawn?
tehuff
Aug 23, 2012
2
Replies
10
Views
7,891
Feb 6, 2014
SteveK
B
Health Informatics ISO 11073 - Centrifuge Device Requirements
Bassman84
Dec 7, 2011
Replies
1
Views
1,439
Dec 7, 2011
Michael Malis
S
Help with EU Medical Device Vigilance Reporting Requirements
samtam
Jan 27, 2014
Replies
0
Views
930
Jan 27, 2014
samtam
S
Help with Massage Device Classification
samuelson
Jul 26, 2013
Replies
2
Views
1,378
Aug 1, 2013
samuelson
F
High Level Disinfection Risk - Neonatal CPAP Device
flyingfrisbee
Nov 18, 2013
Replies
1
Views
1,297
Nov 18, 2013
MIREGMGR
E
Horizontal and Vertical Standards - Definitions in EU Technical File - ER checklist
Ethan Loh
Dec 15, 2010
Replies
1
Views
7,749
Dec 15, 2010
rob73
S
How Directive 2007/47/EEC will affect Medical Devices industries?
sharadmshukla
Aug 18, 2009
Replies
3
Views
4,355
Aug 19, 2009
sharadmshukla
S
How do I create a Technical File for a Class IIa Medical Device
sim.s
Jul 26, 2010
Replies
4
Views
5,787
Jul 30, 2010
Al Rosen
J
How do you Create SOPs for Multiple Authorities?
Jen C
Aug 28, 2013
Replies
8
Views
1,512
Sep 5, 2013
insect warfare
E
How do you monitor Medical Device Off-Label use by Customers & Medical Professionals
ElmerF
Dec 4, 2014
Replies
5
Views
1,428
Dec 6, 2014
Ronen E
How does the eMDVR works? To Whom all should the MDV to be reported?
SK13485
Apr 23, 2018
Replies
6
Views
708
Apr 26, 2018
SK13485
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Forums
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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