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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
1,158
Feb 26, 2019
Ellison
Attachment browser
Sticky
February 2013 Medical Device "State-of-the-Art" updates
Sam Lazzara
Feb 2, 2013
Replies
6
Views
5,864
Feb 26, 2019
Ronen E
Sticky
Medical Device Standards - Difference between IEC and EN Standards
Marc
Oct 27, 2011
2
Replies
13
Views
20,728
Oct 28, 2011
rob73
Discussions
QR Code Standard ISO/IEC 15417:2007 - Does anyone use it?
MDD_QNA
Jan 8, 2020
Replies
2
Views
100
Friday at 7:39 AM
ca_moni
S
Stability accelerated vs. real-time
Sanara
Tuesday at 4:17 AM
Replies
1
Views
58
Tuesday at 8:19 PM
Ronen E
B
ISO 11607-1 for surgical instruments sterilized by end user
BioCPS
Jan 10, 2020
Replies
0
Views
54
Jan 10, 2020
BioCPS
Are GLP required for testing cytotoxicity and soil remaining after sterilization of MD?
MrTetris
Dec 19, 2019
Replies
8
Views
210
Jan 6, 2020
JJ_FDA
Y
Packaging validation for non-sterile Medical Equipment
Yaara
Jan 1, 2020
Replies
1
Views
136
Jan 2, 2020
craiglab
Z
EN 868-8 "required tests" - Rigid sterilization containers
zeypzeyn
Dec 18, 2019
Replies
0
Views
87
Dec 18, 2019
zeypzeyn
N
Per the FDA regulations can a medical device be class I despite that it is sterile?
Nissim Shaked
Jan 22, 2019
Replies
4
Views
350
Dec 15, 2019
Watchcat
B
Class III Medical Device Accelerated conditions
bob44
Dec 4, 2019
Replies
1
Views
159
Dec 4, 2019
Ronen E
M
10993-11 vs 2006 gap analysis
MDRexpert
Nov 21, 2019
Replies
2
Views
173
Nov 22, 2019
MDRexpert
S
Validation of eQMS - Cloud based out of the box solution
smb1191
Oct 4, 2019
Replies
3
Views
301
Nov 20, 2019
LUFAN
B
Product definition for Ethylene Oxide Sterilization Validation
bacillus killer
Sep 27, 2016
Replies
2
Views
1,353
Nov 18, 2019
Banan
N
Going for CE on MD Class 1 ISO 20957-1&2
Nigel-S
Oct 30, 2019
Replies
3
Views
243
Nov 13, 2019
Nigel-S
C
Design Control - Ways of capturing inputs from manufacturing
Chef100
Nov 10, 2019
Replies
5
Views
201
Nov 10, 2019
Ronen E
M
Luer Taper Tolerances - 6% or otherwise - Dimensional Accuracy
micaudwell
Dec 23, 2008
2
3
Replies
23
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27,270
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
236
Nov 1, 2019
Jean_B
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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