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Forums
Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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Other Medical Device Related Standards
Medical Device Related Standards not listed in the above sub-forums.
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FAQs
M
Sticky
Informational
Links to recognized / harmonised / consensus Standards for each market
Mark Meer
Feb 25, 2019
Replies
5
Views
952
Feb 26, 2019
Ellison
Attachment browser
Sticky
February 2013 Medical Device "State-of-the-Art" updates
Sam Lazzara
Feb 2, 2013
Replies
6
Views
5,656
Feb 26, 2019
Ronen E
Sticky
Medical Device Standards - Difference between IEC and EN Standards
Marc
Oct 27, 2011
2
Replies
13
Views
20,382
Oct 28, 2011
rob73
Discussions
B
Class III Medical Device Accelerated conditions
bob44
Wednesday at 2:25 PM
Replies
1
Views
84
Wednesday at 6:34 PM
Ronen E
M
10993-11 vs 2006 gap analysis
MDRexpert
Nov 21, 2019
Replies
2
Views
132
Nov 22, 2019
MDRexpert
S
Validation of eQMS - Cloud based out of the box solution
smb1191
Oct 4, 2019
Replies
3
Views
242
Nov 20, 2019
LUFAN
B
Product definition for Ethylene Oxide Sterilization Validation
bacillus killer
Sep 27, 2016
Replies
2
Views
1,323
Nov 18, 2019
Banan
N
Going for CE on MD Class 1 ISO 20957-1&2
Nigel-S
Oct 30, 2019
Replies
3
Views
215
Nov 13, 2019
Nigel-S
C
Design Control - Ways of capturing inputs from manufacturing
Chef100
Nov 10, 2019
Replies
5
Views
158
Nov 10, 2019
Ronen E
M
Luer Taper Tolerances - 6% or otherwise - Dimensional Accuracy
micaudwell
Dec 23, 2008
2
3
Replies
23
Views
27,146
Nov 7, 2019
Wayne
B
Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU?
bolesen
Oct 30, 2019
Replies
9
Views
177
Nov 1, 2019
Jean_B
H
EO Sterilization Validation - Sterility Testing and Load Configuration
htcoztrk
Oct 30, 2019
Replies
1
Views
120
Oct 31, 2019
planB
B
We need a QMS: file-based templates or software
bob44
Oct 14, 2019
2
3
Replies
23
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561
Oct 25, 2019
John D
D
Performance Qualification per GHTF Guidance
DamienL
Oct 14, 2019
2
Replies
12
Views
320
Oct 18, 2019
TWA - not the airline
R
Inventory management for a small startup device company
racglobal
Oct 10, 2019
Replies
1
Views
121
Oct 10, 2019
indubioush
A
Attachment browser
Cassette Representation - GUI (Graphical User Interface) on my medical device - A mammography Device
Akila.SR
Oct 4, 2019
Replies
0
Views
187
Oct 4, 2019
Akila.SR
W
EO sterilization - what about the pallet?
WalkingCube
Sep 18, 2019
Replies
1
Views
203
Sep 26, 2019
planB
J
Textiles needed for home monitoring device - any suggestions?
Jana Arpakeet
Sep 24, 2019
Replies
1
Views
98
Sep 24, 2019
Ronen E
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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